Event Notification Report for September 01, 2023

AGREEMENT STATE REPORT - MEDICAL EVENT

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

"On August 24, 2023, the licensee informed the Department of an under-dose incident involving cesium-131 (Cs-131). It is reportable per 10 CFR 35.3045(a)(1).

"On August 23, 2023 a patient received prostate seed therapy with Cs-131. The therapy plan detailed the need for 24 needles with 98 Cs-131 seeds total (1.8U/seed). A total of 107 Cs-131 seeds were received by the facility, based on the pre-plan volume. Devices used in the operation included: Ultrasound - BK Medical, BK 3000, serial number: 2003107; Planning System - Varian, Variseed 9.0, serial number: B29WL33; Stepper and applicator - CIVCO, Classic Stepper, serial number: 02107; MICK Medical, Mick TP applicator.

"Seed assay was performed with the activity per seed within acceptable regulatory limits. However, after the medical procedure, more than 37 seeds were found unused. According to the plan, the unused number was supposed to be 9. Thus, a total of 70 seeds were implanted. The physician and patient have been informed. The patient received 201.9 mCi (70 seeds) of the 282.6 mCi (98 seeds) prescribed.

"The cause of the event is unknown at this time. The Department will perform a reactive inspection. More information will be provided as received."

Pennsylvania Event Report ID No.: PA230023.

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 - LOST LESS THAN CAT 3 SOURCE

The following information was received via email from the Illinois Emergency Management Agency and Office of Homeland Security (the Agency):

"The Agency was notified August 24, 2023, by G.E. Healthcare in Arlington Heights, IL to advise a radiopharmaceutical package was missing - presumably in transit. The last known location was the licensee's Arlington Heights, IL facility when it was reportedly given to the [common carrier]. The carrier reports it wasn't scanned at pickup and cannot be accounted for. This package does not represent a significant public safety hazard and there is no indication of intentional theft or diversion.

"The 16 centimeters squared package was labeled Yellow-II (TI of 0.1), UN2915 and contained a single 10mL shielded vial. The activity of In-111 was 1.5 millicuries at the time of shipment, but has since decayed to approximately 0.6 millicuries. It was reportedly offered for shipment on August 21, 2023, for delivery to the customer in West Virginia on August 22, 2023. After failure to arrive, the licensee initiated a search and found the carrier's tracking system states it was never received. The licensee has searched their facility and reviewed inventory and survey records; all of which indicate the package was conveyed to the [common carrier] for transit into commerce. GE Healthcare contacted the customer, (Pharmalogic in Bridgeport, WV) which confirmed that the package had not been received. After several reviews of the package's status and conversations with various [common carrier] personnel, it has been established that the package cannot be located.

"A site visit by Agency inspectors is not planned at this time. This matter will continue to be tracked until an update is available or the package has decayed to background levels."

Illinois Item Number: IL230021

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

NOTICE OF MISSED 24-HOUR NOTIFICATION PER 10 CFR 26.719(b)(1)

The following information was provided by the licensee via email:

"On 07/05/2023, at 0130 hours, a security officer found a 1 ounce bottle of vanilla extract in the protected area. Alcohol was identified as an ingredient on the ingredients label. It was determined the alcohol by volume (ABV) for vanilla extract is 35 percent ABV, above the 0.5 percent ABV considered low alcohol content. Vanilla extract is not listed as a prohibited item within Comanche Peak procedures.

"The initial reporting assessment of not reportable has been questioned during an in-process security access inspection and reassessed as a reportable condition. Emergency Notification System notification should have been made by 0130 CDT on 07/06/2023. This report restores compliance."

The NRC Resident will be notified.