Event Notification Report for August 31, 2023

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

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.

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.