Event Notification Report for August 30, 2023

AGREEMENT STATE REPORT - MEDICAL EVENT

The following information was received via email from the Kentucky Department for Public Health:

"Kentucky Radiation Health Branch (KY RHB) was notified on 8/22/2023 by a representative from University of Louisville Hospital, of an I-125 radioactive seed localization that was implanted on 10/4/2022. The patient went to surgery on 10/5/2022 to have the tissue resected and the seed removed. The physician resected the tissue along with removing what he thought was the seed.

"When the patient came back yesterday (8/21/2023), they found that the seed was still there. The physician had removed a clip (a non-radioactive small metallic object that somewhat resembles a seed). The patient will be having the seed removed due to needing other tissue removed at a future date to be determined.

"Based on a dose calculation, the [Radiation Safety Officer] RSO has calculated the radiation dose as 74 cGy (rad) dose to the breast tissue. With the medical event requirements being over 50 rem to an organ or tissue, this makes it a medical event.

"The RSO will write up a report and mail to KY RHB within 15 days."

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.

AGREEMENT STATE REPORT - MEDICAL EQUIPMENT FAILED TO FUNCTION AS DESIGNED

The following information was received via email from the Pennsylvania Department of Environmental Protection (the Department):

"On August 21, 2023 the licensee informed the Department of a medical event where the equipment failed to function as designed. This is reportable under 10 CFR 30.50(b)(2).

"A patient was scheduled for an intravascular brachytherapy (IVBT) patient treatment using a Beta-Cath Strontium 90 device (s/n 91273) and upon source retraction the source failed to return to the transfer device due to a kink in the catheter. An emergency 'bailout' procedure was performed, with the cardiologist removing the delivery catheter and guidewire from the patient. The delivery catheter was left attached to the transfer device and placed it into the temporary plexiglas 'bailout' box. The patient was surveyed to confirm the source had been removed. The 'bailout' box was visually inspected and surveyed to confirm the source was in the catheter in the box. This box was then transferred to the radiation oncology secure storage area. The device will be returned to the manufacturer for inspection. No overexposures were reported.

"The cause of the event is unknown at this time.

"The Department will perform a reactive inspection. More information will be provided as received."

PA Event Report ID Number: PA230022

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.

* * * UPDATE FROM JOHN CHIPPO TO DONALD NORWOOD AT 1357 EDT ON 8/23/2023 * * *

The following information was received via email from the Department.

"The event type has been changed from a medical event to a Part 30 equipment event.

"The Department has learned that the authorized user said that treatment was complete and the source did not enter the device within 3 seconds so they started emergency removal of catheter from the patient and placed it in the 'bailout' box; total time from end of treatment to the catheter/device in the emergency box was approximately 10 seconds. The kink in the catheter was noted after it and the source were approximately 15 cm from where it entered the patient thus no overexposure or unintended dose.

"Device make, model, serial number: Best Vascular, Inc, A1000 Series Models, Transfer Device s/n 91273.
"Radionuclide: Sr-90; Jacketed Radiation Source Train s/n ZB948 (60 mm source train) (24 sources).
"Source strength(s): 3.13 Gbq (84.6 mCi) total; [3.52 mCi/source * 24 sources]; Assay date 12/3/2003; Activity as of August 21, 2023 = 1.92 Gbq (51.9 mCi) total.
"Dose patient received:18.4 Gray @ 2 mm; (vessel 3.0 mm).
"Dose patient prescribed:18.4 Gray @ 2mm (vessel 3.0 mm)."

Notified R1DO (Gray) and NMSS Events Notification email group.

AGREEMENT STATE REPORT - STUCK OPEN SHUTTER

The following information was received via email from the Illinois Emergency Management Agency (the Agency):

"The Agency was contacted on August 22, 2023, by Combined Metals of Chicago, LLC in Elgin IL to advise of a stuck open shutter on a 100 mCi Sr-90 fixed gauge. The reportable equipment failure was discovered by the maintenance team during the morning hours on August 22, 2023. The Radiation Safety Officer [RSO] was promptly advised and took appropriate steps to ensure adequate control of the gauge and area until the shutter is repaired. No personnel exposures occurred as a result. The incident was reported to the Agency within 24 hours as required under 32 Ill. Adm. Code 340.1220(c)(2). Agency staff will perform a combined reactionary/routine inspection next week to review the event and confirm that appropriate corrective actions were taken.

"Details: Radioactive Materials Staff were contacted via email at 0955 EDT on August 22, 2023 by the RSO at Combined Metals of Chicago, LLC (IL-02397-01) regarding a reportable equipment failure. The stuck open shutter on a Radiometrie thickness gauge containing 100 mCi of Sr-90 was identified by the maintenance team during typical operations early this same morning. The RSO confirmed that the gauge will remain in its mounted condition and that a 1 inch Lexon polycarbonate shield/guard (used during typical running operations) was placed on the gauge. Exposure readings reported during a 2019 inspection by the Agency reported a maximum exposure rate of 600 microrem/hr at contact with the gauge (shutter open). Operators/maintenance staff were immediately advised of the inoperable shutter and per the RSO remained at least 6 feet from the gauge during typical operations. Currently no product is running through the affected line. Agency staff will verify reported actions taken by the RSO during a reactionary/routine inspection to be performed next week. The manufacturer was notified and is scheduled to be on site Thursday, August 24, 2023 to repair the shutter. No personnel exposures were reported and actions taken by the RSO appear adequate to ensure the safety of plant personnel pending repair of the shutter."

Illinois Item Number: IL230020

AGREEMENT STATE REPORT - DAMAGED MOISTURE DENSITY GAUGE

The following information was received via email from the North Carolina Radioactive Material Branch:

"The Licensee Authorized User was on a construction site in Dunn performing compaction testing with the referenced nuclear gauge. The area was an open fill section with dump trucks back dumping upon arrival. The contractor requested a test for the current fill layer and the field technician randomly picked a location. There were no dump trucks onsite at the time of the testing. After taking the density test with Gauge 1029, the field technician properly placed the source rod back in the safe position prior to the incident. The technician turned to tell the contractor the test results, then took a few steps (about 12 feet) away from the gauge due to the equipment noise. When he turned around to get the gauge, a dump truck was about twenty feet away heading towards the gauge. The technician immediately started flagging and yelling for the truck to stop due to the proximity of the work area. The driver's attention was in another direction, so he didn't hear or see the field technician's efforts to prevent the accident. The driver ran over the gauge and stopped to see what happened. After a brief conversation, the truck driver left the site. The field technician notified the local Radiation Safety Officer (RSO) and Office Manager of the incident. The RSO instructed the employee to secure the area and to prevent access until he could get there. The local RSO, Office Manager, and Director of Subsidiary Safety responded and arrived at the incident location within 1 hour of the notification. ECS called the North Carolina Emergency Management telephone number and informed them that a nuclear moisture - density gauge had been run over by construction equipment, that the source rod had come out of the gauge but had been placed back into the shielded position.

"Upon arrival, the field technician and grading contractor employees were interviewed by the RSO. The gauge and test location were surveyed using a calibrated survey meter (Model Radalert, Serial No.: 7326, last calibrated March 26, 2023) by the RSO while approaching the gauge to ensure that the source was in the shielded position and that the transport index was within the acceptable range. The source rod was bent about 6 inches up and the guide rod was broken. The source was confirmed to be in the secured safe position and after the survey was placed in the transport case. Due to the bend handle, the case lid would not close fully on the gauge transport case, so it was pulled tightly to within 2 inches of closing and secured with a python cable and locked.

"A nuclear safety stand down occurred with all parties involved in the incident upon securing the gauge. The field technician was immediately reinstructed in proper gauge handling requirements. The licensee also scheduled a formal retraining session for the field technician for the following day.

"All ECS Authorized Users at the licensee's other North Carolina location will receive retraining in gauge security and situational awareness within the next 2 weeks.

"A leak test was performed on gauge 1029 and the test specimen was transported to Instrotek. No leakage was detected.

"Gauge Manufacturer: Instrotek
Model Number: 3500
Serial Number: 1029

"Cs-137 Source
Manufacturer: Eckert and Ziegler
Model Number: Cs-137
Serial Number: cz-2185
Activity: 10 mCi

"Am-241 Source
Manufacturer: Eckert and Ziegler
Model Number: AmBe-241
Serial Number: 127/09
Activity: 40 mCi"

Ge-68 SOURCE MISSING FOLLOWING MAINTENANCE

The following is a summary of information provided by the licensee via phone and email:

The licensee reported two missing Ge-68 sources with an activity of 0.312 mCi per source. The sources were stored on a PET CT mobile imaging unit used throughout the State of Michigan. The mobile unit went for repair to TDC Trailer in Rensselaer, IN. While the unit was at TDC Trailer, the unit needed a structural repair which required items in the camera room to be removed from their designated place. The trailer repairman unbolted the source holder from the floor and moved it to the hot lab and placed it in a radiopharmaceutical dose container. The licensee believes the sources were inadvertently picked up by PetNet Radiopharmacy as part of their routine pick up of empty radiopharmaceutical cases on August 16, 2023.

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