Event Notification Report for August 12, 2022

AGREEMENT STATE REPORT - UNDERDOSE OF Y-90 SIR-SPHERES

The following information was received from the Massachusetts Radiation Control Program (the Agency) via email:

"On 8/3/2022 at 1444 EDT, the licensee reported [to the agency (MA Department of Public Health Radiation Control Program)] a medical event for Sirtex Wilmington LLC SIR-Spheres Y-90 microspheres (SS&D MA-1229-D-101-S) emerging technology for total administered activity that differed from prescribed treatment activity as documented in the written directive by 20 percent or more. A portion of a two-site Y-90 16.2 mCi microsphere therapy treatment delivered to the patient liver on 8/2/22 remained in the delivery system causing delivery of 12.7 mCi Y-90 of the prescribed 16.2 mCi. The error was discovered the next morning during final post-treatment calculations. The administered dose to the treatment area differed from the prescribed dose by 21.6 percent. The licensee stated that the cause, including possible equipment malfunction, has not yet been determined. The prescribing physician and referring physician have been notified. The physician is to notify the patient (not yet confirmed). The licensee stated no negative health effects to the patient due to the situation. No additional Y-90 therapy treatment is expected due to this situation. The licensee stated that all Y-90 was accounted for. The licensee is to submit a written report within 15 days of discovery date. This is a next day reportable medical event per regulation.

"Investigation is ongoing. The agency considers this event docket to still be open."

MA Event Number: TBD

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.

EN Revision Imported Date: 8/8/2022

EN Revision Text: AGREEMENT STATE REPORT - LOST/MISSING CATEGORY 2 RADIOACTIVE MATERIAL SHIPMENT

The following information was received from the Massachusetts Radiation Control Program via email:

"QSA Global reported via telephone at 1400 EDT on 8/4/2022 [to the agency (MA Department of Public Health Radiation Control Program)] that a 6/30/2022 shipment from Australia, containing thirty-two Ir-192 sealed sources totaling 134 Ci and two Se-75 sealed sources totaling 8.38 Ci, was missing in transit. The shipment departed from Sydney, Australia (SYD) via Qatar Airways on or about 7/1/2022 and arrived at Chicago O'Hare International Airport (ORD). QSA Global stated last known (scanned) location was at ORD on 7/20/2022. QSA Global was informed that shipment was missing at 1345 EDT on 8/4/2022. This shipment included three 34x34x40 cm, RQ UN2916, Yellow-II, Type B packages containing Ir-192 with a Transport Index of 0.3 DIM, two 49x49x53 cm, RQ UN2916, Yellow-II, Type B packages containing Ir-192 with a Transport Index of 0.2 DIM, and one 25x21x43 cm, RQ UN2916, Yellow-II, Type B package containing Se-75 with a Transport Index of 0.1 DIM, at time of shipment. QSA updated last known location by later stating that the shipment was picked up in Chicago by Forward Air Corporation trucking company on 7/21/22 and arrived in Boston on 7/25/22 (current last known location is Forward Air facility in Boston).

"This situation is an immediately reportable event per regulation.

"Search for the missing shipment by Forward Air Corporation is ongoing.

"The agency currently considers this docket to still be open."

MA Event Docket Number: TBD

Notified external: DHS SWO, FEMA Ops Center, USDA Ops Center, HHS Ops Center, DOE Ops Center, DHS CISA Central, and EPA EOC and via E-mail: FDA EOC, Nuclear SSA, FEMA National Watch Center, and CWMD Watch Desk.

* * * UPDATE ON 8/5/2022 AT 1532 EDT FROM TONY CARPENITO TO MIKE STAFFORD * * *

The following was received from the Massachusetts Radiation Control Program via email:

"Shipment discovered on loading dock at carrier (Forward Air Corporation) facility in Boston 8/4/22. Receiver licensee (QSA Global Inc.) reported receipt of shipment on 8/5/22 and confirmed all six individual package seals were observed to be intact."

Notified internal: R1RDO (Henrion), IR MOC (Crouch), and ILTAB (MacDonald), and via email: NMSS (Williams), INES (Smith), NMSS Events Notification, and ILTAB.

Notified external: DHS SWO, FEMA Ops Center, USDA Ops Center, HHS Ops Center, DOE Ops Center, DHS CISA Central, and EPA EOC and via E-mail: FDA EOC, Nuclear SSA, FEMA National Watch Center, and CWMD Watch Desk.

THIS MATERIAL EVENT CONTAINS A 'Category 2' LEVEL OF RADIOACTIVE MATERIAL

Category 2 sources, if not safely managed or securely protected, could cause permanent injury to a person who handled them, or were otherwise in contact with them, for a short time (minutes to hours). It could possibly be fatal to be close to this amount of unshielded radioactive material for a period of hours to days. These sources are typically used in practices such as industrial gamma radiography, high dose rate brachytherapy and medium dose rate brachytherapy. For additional information go to http://www-pub.iaea.org/MTCD/publications/PDF/Pub1227_web.pdf

AGREEMENT STATE REPORT - ATTEMPT TO OBTAIN MATERIAL WITHOUT LICENSE

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

"On August 4, 2022, this Agency received information that a former licensee was trying to obtain 500 microCi of Am-241 without a license. The material would reportedly be used for calibration. The issue was reported to the appropriate Agency in California because that is where the seller is located. An informal report was made to the NRC in Arlington, Texas. It was decided that this needed to be reported to the FBI which was accomplished on this same day. The seller has reported that they will not provide a quote to the former licensee and hence will not be supplying the material. It is not clear if this is a misunderstanding or an attempt to gain material while bypassing regulations. This Agency will not investigate this matter immediately but will give the FBI some time to investigate. No further information is expected in the near future, but information will be provided when obtained per SA-300."

Texas Incident Number: I-9944

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

EN Revision Imported Date: 8/8/2022

EN Revision Text: AGREEMENT STATE REPORT - THEFT OF RADIOACTIVE GAUGE

The following information was provided by the licensee via email:
During an inspection on 7/26/22, the RSO [Radiation Safety Officer] of Advanced Geotechnical Solutions stated that on March 6, 2021, an Authorized User of radioactive gauges for Advanced Geotechnical Solutions discovered that his SUV had been broken into and the radioactive gauge Troxler, 3430, serial #70783 that he had checked out from the permanent storage site at [REDACTED], had been stolen. The Authorized User had transported the radioactive gauge to his personal residence and left it locked in his vehicle rather than transport it back to the permanent storage location in Escondido. The Authorized User reported the theft to his RSO, and to the San Diego Police Department, and the RSO reported the theft to Cal OES [California Governor's Office of Emergency Services] on 3/7/21, instead of to the Brea, CA office since it was a weekend. The report of the lost gauge apparently did not get to the Brea office, and consequently no investigation was conducted, nor was the theft reported to NRC.

The RSO had contacted local newspapers in an attempt to retrieve the stolen radioactive gauge, as well as notifying local servicing vendors of radioactive gauges to be alert for the serial number of the stolen gauge in case it turns up for service, but the gauge has not been recovered. The investigation is ongoing, including why the Cal OES report did not get to the Brea, CA, RHB [Radiologic Health Branch] inspection office.



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 - POTENTIAL OVEREXPOSURE TO EXTREMITY

The following information was received from the Massachusetts Radiation Control Program (the Agency) via email:

"Licensee reported employee weekly finger ring exposure exceeding 50 rem (67.569 rem for wear period, 7/4/22-7/10/22) a situation reportable within 24 hours per 105 CMR 120.282 (B) (1) (c). The other finger ring dosimeter worn by the subject employee received 31.509 rem exposure for same wear period. Exact cause of exposure not yet known. Licensee investigation ongoing. Licensee, a radiopharmaceutical manufacturer/distributer, stated that subject employee does perform work involved with F-18 radiopharmaceutical manufacturing operations.

"The Agency considers this matter still open."

MA Event Number: TBD