Event Notification Report for February 28, 2023

AGREEMENT STATE REPORT - LOST DEVICE

The following information was provided by Iowa Department of Health and Human Services via email:

"In the process of a registrant closing out their general license, the registrant identified that a generally licensed 3M model 703 handheld static eliminator (s/n: 7030250) containing hydrogen-3 with a current activity of 20 millicuries (manufactured in 1982 with 200 millicuries) had been lost. In 2015, the registrant had three (3) 703 devices, in which two (2) were disposed of through the manufacturer. No other records of sale, transfer, or disposal could be identified.

"The registrant spent 400 man-hours searching their facility, methodically sectioning off and checking all storage locations, interviewing current and former employees, contacting vendors who had conducted leak test services on other devices, and contacting radioactive waste disposal groups who have handled waste in the past. None had any records of the missing unit. It is the registrant's belief that the unit was likely removed from the site sometime before 2018. No occupational illnesses or injuries have been reported or would likely occur from the loss of this device due to its age and characteristics."

Iowa Incident Number: IA230002

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: 5/24/2023

EN Revision Text: AGREEMENT STATE REPORT - DOSE MISADMINISTRATION

The following information was provided by the Maryland Department of the Environment (MDE) via email:

On 04/14/2023 at 0951 [EDT], the MDE discovered an unsigned, undated report from the University of Maryland Medical Center, Baltimore, MD, that a medical misadministration had occurred on 02/28/2023. [After] contacting a health physicist and the Radiation Safety Officer (RSO) [at the University of Maryland], they confirmed that the event had actually occurred. A dose of 104.73 mCi of Ludotadipep [Lu-177] was being administered to a patient as part of a phase 1 clinical trial to treat metastasis. During the procedure, catheter infiltration (catheter movement) occurred resulting in a significant portion of the dose remaining in the upper left arm. The study sponsor was informed. Subsequent gamma scans showed that within 24 to 48 hours the dose had migrated to the intended treatment site. MDE is following up with the RSO and medical staff to confirm that the actual dose delivered to the treatment site was within 20 percent of the dose prescribed in the written directive. The University of Maryland staff has determined that an unintended dose estimated at 157 Rem had been delivered to the upper arm tissue. As of 04/14/2023, no ill effects have been observed, and the patient has been scheduled to resume subsequent treatment. This event is being reported under 10CFR 35.3045 (a)(1)(ii) B `. a dose that exceeds 50 Rem to an organ or tissue from administration of a radioactive drug containing byproduct material by the wrong route of administration'."

* * * RETRACTION ON 5/23/23 AT 1501 EDT FROM PAUL KOVACH TO BILL GOTT * * *

The following information was provided by the Maryland Department of the Environment (MDE) via email:

"[The MDE] has been informed that the NRC medical team has reviewed this event notification and determined that this is not a reportable event under 10 CFR 35.3045. The medical team determined that, although not explicitly named as such, this event notification describes an extravasation. Extravasations are currently exempted from medical event reporting due to Commission policy, however this may change in the near future. Please note that the NRC does not consider extravasations as 'wrong route of administration,' as stated in 10 CFR 35.3045(a)(1)(ii)(B).

"On May 19, 2023, the patient's physician at [University of Maryland Baltimore] (UMB) confirmed to [the MDE] that this event can be considered as an extravasation."

Notified R1DO (Jackson), NMSS (Rivera), and NMSS Events Notification via email.

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 / MISSING SOURCES

The following information was provided by the Illinois Emergency Management Agency (the Agency) via email:

"As a result of an ongoing Agency investigation into unresponsive general licensees, the Agency became aware today that two generally licensed fixed gauges, one containing 150 millicuries of Am-241 and the other 80 millicuries of Am-241, were likely disposed of as scrap in February 2023. The quantity of radioactive material involved, while unlikely to be dangerous to the public, is immediately reportable to the Agency and NRC. Agency staff will conduct a reactive inspection to determine if any additional information on the gauges is available (e.g., [are the items] still at the scrap yard or potentially auctioned during site closure).

"The licensee was operating at Glenview, IL, up until 2022. At that time, the company was in possession of an NDC Technologies model 102X (s/n 591181) containing 80 mCi of Am-241, and an NDC Technologies model 103X (s/n 591171) containing 150 mCi of Am-241. According to the facility's property manager, the facility closed in August 2022. Reportedly, the contents of the building were auctioned off and all remaining items were recycled for scrap in February 2023. The property manager stated that at the time they did not realize there was radioactive material in the scrap. This investigation remains ongoing."

Illinois Item Number: IL250032

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