Event Notification Report for August 17, 2023

AGREEMENT STATE REPORT - MEDICAL UNDERDOSE

The following information was provided by the Wisconsin Department of Health Services (the Department) via email:

"On August 9, 2023, the Department was notified by the licensee of a yttrium-90 (Y-90) TheraSphere medical event that had occurred on July 13, 2023. The licensee's radiation safety officer performed a records review on August 2, 2023, and identified a written directive indicating a potential underdose to the patient. After confirming that the documentation was correct on August 8, 2023, the licensee determined that a reportable event had occurred.

"The prescribed activity to the patient was 1.07 GBq. The licensee initially calculated a delivered activity of .86 GBq based on pre- and post-administration surveys. The radiation safety officer was not able to replicate this calculation and determined that the delivered activity was approximately .781 GBq. This is a delivered activity of 72.99 percent. Utilizing the TheraSphere worksheet, the licensee calculated that the patient received 73.4 percent of the prescribed dose.

"The licensee will be notifying the patient. There is no anticipated harm to the patient, or exposure to any additional individuals."

Event Report ID No.: WI230006

A Medical Event may indicate potential problems in a medical facility's use of radioactive materials. It does not necessarily result in harm to the patient.

UNANALYZED CONDITION

The following information was provided by the licensee via mail:

"It was determined that the Urenco United States of America (UUSA) safety analysis did not analyze for stacked, criticality safe (CSA) containers when not in an engineered storage array. This potentially results in an inadequate analysis.

"Urenco USA stores CSA containers in isolation on the floor and spaces them 60 centimeters apart, prior to performing IROFS [Items Relied on For Safety] 58a mass determination and placing a container in an array. However, an analysis has not determined whether dropping a container, or stacking a container, onto another container stored in this way, could result in exceeding the Code of Federal Regulations Title 10 Part 70.61 requirements. Currently, there are no containers stacked in this way.

"Urenco USA has stopped all work regarding moving the containers in areas affected by accident sequence DS1-9. The plant is in a safe and stable condition."

AGREEMENT STATE REPORT - LOST SHIPMENT

The following information was provided by the Florida Bureau of Radiation Control via email:

"The Texas DSHS [Department of State Health Services], called to report a lost shipment of Y-90, with a final delivery of Mayo Clinic, Jacksonville. The original supplier was Boston Scientific (Storage) [the Y-90 was, however, ordered by Boston Scientific and shipped from a Texas location] . The product was shipped by MNX Global Logistics Grp, Texas License #07144-000. The location of the product is unknown at this time.

"An investigation is in progress."

FL Incident Number FL23-124

This event was also reported by Texas under EN 56672.

THIS MATERIAL EVENT CONTAINS A 'Less than Cat 3' LEVEL OF RADIOACTIVE MATERIAL

Sources that are "Less than IAEA Category 3 sources," are either sources that are very unlikely to cause permanent injury to individuals or contain a very small amount of radioactive material that would not cause any permanent injury. Some of these sources, such as moisture density gauges or thickness gauges that are Category 4, the amount of unshielded radioactive material, if not safely managed or securely protected, could possibly - although it is unlikely - temporarily injure someone who handled it or were otherwise in contact with it, or who were close to it for a period of many weeks. For additional information go to http://www-pub.iaea.org/MTCD/publications/PDF/Pub1227_web.pdf

AGREEMENT STATE REPORT - LOST SHIPMENT

The following information was provided by the Texas Department of State Health Services (the Department) via email:

"On August 9, 2023, the Department was notified by a licensee of radioactive material lost in shipment. The material was 1.82 GBq (49 mCi) of Y-90 Theraspheres which is greater than 1000 times the Appendix C value for Y-90 (10 microcuries). The owner of the material is the manufacturer of the microspheres. The manufacturer ships the material to the Texas licensee who is located near a major airline hub. The Texas licensee then stores the material until the owner sends an order for rapid shipping to a medical facility. At which point, the Texas licensee ships the material via a common carrier to the address on the order. The manufacturer is responsible for confirming the facility receiving the package has a radioactive material license.

"On July 27, 2023 the Texas licensee received an order from the manufacturer to ship four sets of Theraspheres to a licensee in Florida. The four sets were each in separate type A packages. The Texas licensee has closed circuit television of the common carrier picking up the four packages which were sent 'Priority Overnight'. On July 28, 2023, three of the packages arrived at the Florida licensee. The Texas licensee contacted the common carrier asking about the fourth package which has a tracking number of [deleted]. After some investigation, the common carrier reported that the package had not left their Irving, TX facility near the Dallas Fort Worth airport. Three of the packages had scans leaving that facility but not the fourth and missing package. A transit facility in Greensboro, NC reported that they did not have the package. They reported scanning three packages on the way to the Florida licensee.

"On August 3, 2023, the common carrier advised the Texas licensee that they had closed the lost claim and were no longer looking for the package.

"The Department has asked the Texas licensee to contact the dangerous goods section of the common carrier and request their assistance. This Department has also notified the Florida Radiation Control program of the incident. This Department is waiting for contact information for the radiation safety officer of the manufacturer and owner of the material. Once obtained the Department will notify the appropriate state agency. Further information will be provided per SA-300."

Texas Incident number: 10045
Texas NMED number TX230037

This event was also reported by the State of Florida under EN 56671.

THIS MATERIAL EVENT CONTAINS A 'Less than Cat 3' LEVEL OF RADIOACTIVE MATERIAL

Sources that are "Less than IAEA Category 3 sources," are either sources that are very unlikely to cause permanent injury to individuals or contain a very small amount of radioactive material that would not cause any permanent injury. Some of these sources, such as moisture density gauges or thickness gauges that are Category 4, the amount of unshielded radioactive material, if not safely managed or securely protected, could possibly - although it is unlikely - temporarily injure someone who handled it or were otherwise in contact with it, or who were close to it for a period of many weeks. For additional information go to http://www-pub.iaea.org/MTCD/publications/PDF/Pub1227_web.pdf

AGREEMENT STATE REPORT - LOST RADIOACTIVE SOURCE

The following information was provided by the California Radiation Control Program (RHB) via email:

"On 7/12/23, Tesla, San Rafael facility contacted RHB to report a lost radioactive source. The lost item was a Po-210, 10 mCi source, Model P-2021-Z705, serial number A2LZ130 (air-gun), originally shipped to the facility by NRD, LLC on 5/8/2020, (based on this information, current activity is approximately 26 microcuries). The source was used to blow dust off of auto body panels and prevent static buildup prior to painting.

"The employees at the shop could not provide an estimate of when the last time the device was used and believe that the device may have been disposed of in the trash. Facility will be transitioning to an anti-static tool that does not utilize a radioactive source."


THIS MATERIAL EVENT CONTAINS A 'Less than Cat 3' LEVEL OF RADIOACTIVE MATERIAL

Sources that are "Less than IAEA Category 3 sources," are either sources that are very unlikely to cause permanent injury to individuals or contain a very small amount of radioactive material that would not cause any permanent injury. Some of these sources, such as moisture density gauges or thickness gauges that are Category 4, the amount of unshielded radioactive material, if not safely managed or securely protected, could possibly - although it is unlikely - temporarily injure someone who handled it or were otherwise in contact with it, or who were close to it for a period of many weeks. For additional information go to http://www-pub.iaea.org/MTCD/publications/PDF/Pub1227_web.pdf

PART 21 REPORT - RELAY MECHANICAL PROBLEM

The following information is a synopsis provided by the licensee via facsimile:

Cooper Nuclear Station completed an internal Part 21 evaluation concerning a batch of relays procured under the same purchase order from General Electric Hitachi. Following the failure of a relay, an independent laboratory identified a mechanical problem with the hinged armature, resulting in the relay potentially failing to return to its de-energized state. The relays are not currently installed in a safety related application. The NRC Resident has been notified. A written notification will be provided within 30 days.

Affected known plants include only Cooper at the time of the notification.

AGREEMENT STATE - SHIPPING INCIDENT

The following information was provided by the Washington State Department of Health via email:

"A low specific activity (LSA)-2 excepted package arrived at [the licensee's] facility with a wet corner and a minor liquid drip. The package contained resin for Cr-51 with total activity of between 5 to 7 mCi of U-233, U-234, and U-236 isotopes. No contamination [was detected].

"The incident is currently being investigated. The shipper was suspended. The shipper will be required to submit a root cause analysis and corrective actions."

Washington incident number: WMS-DOT-23-05

NON-AGREEMENT STATE REPORT - LOSS OF RADIOACTIVE SEEDS
The following information was provided by the Defense Health Agency via email:

"The discovery of the loss of 10 radioactive (0.300 mCi each, I-125; total of 3 mCi) seeds used for localization of non-palpable breast lesions occurred on August 10, 2023, when mammography reported a Pyxis inventory discrepancy to health physics (HP). The seeds were likely lost between August 3, 2023, and August 10, 2023.

"The Brooke Army Medical Center (BAMC) breast imaging (mammography) section is missing 10 radioactive seeds from the mammography Pyxis. The loss of 10 radioactive (0.300 mCi each, I-125; total of 3 mCi) seeds used for localization of non-palpable breast lesions occurred on August 10, 2023 (batch number 56406). This batch of 10 seeds was received from the nuclear medicine pharmacist and logged into the BAMC health physics radiological science lab (RSL) seed tracking log on May 11, 2023. A second batch of 10 seeds (batch number 56668) was retrieved by mammography personnel from nuclear medicine and logged in to the BAMC health physics RSL seed tracking log on June 15, 2023. As of June 15, 2023, the mammography Pyxis had 20 radioactive seeds present.

"The first procedure, using radioactive seeds from either batch, was August 3, 2023. When the mammography nurse went to log the seed used on August 3, 2023, into the tracking log (seed number 56668-1), she noticed that no seeds from the number 56406 batch had been used. This is atypical because they are always used in sequential order. At this time, she also noticed that the number 56406 batch (received on May 11, 2023) was physically placed behind the number 56668 batch (received June 15, 2023) in the designated Pyxis bin. This is also atypical, as seeds are used in sequential order from oldest batch to newest batch.

"Following the August 3, 2023, procedure, the seed count, post procedure, was 19 radioactive seeds (9 in batch number 56668 and 10 in batch number 56406). The next radioactive seed was placed on August 10, 2023 (seed number 56668-2) giving a radioactive seed count of 8 in batch number 56668. At this time, it was discovered that the entire batch of number 56406, seeds 1-10, was missing from the Pyxis. Health physics confirmed today, August 11, 2023, that missing batch number 56406, seeds 1-10, is not currently expired, and should not have been removed from the Pyxis.

"The current seed receipt and exchange process is once the seeds are received in mammography from nuclear medicine they are placed in the Pyxis. A note is left in the Pyxis for the logistics technician to only update the count in the Pyxis. The established procedure is that the logistics personnel are not to remove any seeds from the Pyxis whether they are expired or not, and to only to update the count. When seeds expire, they are retrieved by health physics after notification by mammography staff.

"The process for removing expired seeds in the Pyxis is to bundle them and label them as expired. Health physics is contacted for pick up. Seed packaging information is copied and signed by health physics. Health Physics takes a copy, and a copy of the transfer is retained by mammography team. BAMC has transitioned 90 percent of radioactive seed utilization to magseeds.

"On Friday morning, August 11, 2023, HP met with logistics and mammography personnel. The seeds were searched for by multiple representatives from HP, mammography and logistics personnel. The Pyxis system in mammography was thoroughly searched along with logistics areas that expired products are routed through to include sharps containers and mammography work areas. Due to the seeds being shielded, the RAM waste alarm log was not reviewed. If logistics accidentally removed the seeds from the Pyxis for disposal, the seeds would show up on a transfer receipt before being packaged for waste disposal to the landfill. At 1500 on August 11, 2023, BAMC HP declared the seeds lost. HP requested that all Pyxis systems on the 1st floor be searched for the seeds in case they were inadvertently placed there during inventories.

"There was no mission impact to healthcare. This is an NRC reportable event.

"The corrective actions taken were to immediately remove the remaining 8 seeds from the Pyxis and currently store them in the radioactive material (RAM) waste shed until one is required for a procedure. Mammography was informed of the new procedure in which they will contact HP the day before a scheduled procedure to coordinate the delivery of a seed from HP. This action ensures that only HP has possession of seeds until one is needed.

"All RSL seeds will be in possession of HP and locked in the storage shed until mammography needs one for a procedure. The chain of custody starts and ends with HP, thus preventing logistics from mistakenly removing them from the Pyxis system."

THIS MATERIAL EVENT CONTAINS A 'Less than Cat 3' LEVEL OF RADIOACTIVE MATERIAL

Sources that are "Less than IAEA Category 3 sources," are either sources that are very unlikely to cause permanent injury to individuals or contain a very small amount of radioactive material that would not cause any permanent injury. Some of these sources, such as moisture density gauges or thickness gauges that are Category 4, the amount of unshielded radioactive material, if not safely managed or securely protected, could possibly - although it is unlikely - temporarily injure someone who handled it or were otherwise in contact with it, or who were close to it for a period of many weeks. For additional information go to http://www-pub.iaea.org/MTCD/publications/PDF/Pub1227_web.pdf

PART 21 INTERIM REPORT - FAILURE OF CURTISS WRIGHT SUPPLIED SAFETY RELATED RELAY

The following is a summary of the Part 21 report provided by Curtiss Wright:

On June 20, 2023, Duke Energy sent a letter to Curtiss Wright (CW) to formally notify them that a Tyco (Agastat) relay had failed. Duke Energy had identified certain contacts that were found sticking in the open position.

The relay was returned to CW for evaluation; however, CW could not duplicate the failure. As the relay is questionable for reliable service, CW is having the relay returned to Tyco for their evaluation. Once the evaluation is complete, the current report will be updated. CW anticipates an update to the notification with final results by October 15th.

Affected plant: Catawba