Event Notification Report for June 12, 2025

AGREEMENT STATE REPORT - RECOVERED SOURCES

The following information was provided by the New Jersey Bureau of Environmental Radiation Radiological & Environmental Assessment Section (NJDEP) via phone and email:

"On June 12, 2025, NJDEP was notified that three containers of waste were rejected at Stericycle in Elizabeth after triggering their radiation alarm. Stericycle indicated that the waste originated from the licensee, SOFIE Co. A maximum reading of 10 kcpm [kilo counts per minute] was observed, with a background of 4 kcpm. The radiation safety officer (RSO) of SOFIE was contacted and confirmed that all sealed sources were still within their possession. They indicated the waste was likely short-lived F-18. With this understanding, the waste was allowed to decay for a few days. Upon resurveying, no decrease in radiation levels was observed. The RSO stated that it was then likely to be filters which collect activation waste during cyclotron production. Staff from NJDEP responded at this time, and collected exposure rate readings on contact with the containers, which ranged from 36.3 micro-R/h to 236 micro-R/h. A gamma spectrometry analysis made preliminary identifications of Co-56, Co-57, and Co-58, which are expected activation isotopes. SOFIE then retrieved the containers and returned them to their facility to conduct an investigation. It was noted that the waste log indicated that two containers were closed without proper documentation of an outgoing survey to confirm background levels. The other container was surveyed and indicated background levels, which was inaccurate. Full investigation details are still pending.

"The root cause is under investigation"

Incident or investigation number: 452369-INV250001

EXTERNAL CONTAMINATION ON PACKAGING

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

Hawaii Pacific Health radiation safety officer received a call that Pali Momi Medical Center received a package with external technetium-99m loose surface contamination. The package contained indium-111 which was intact. The swipes on the outside of the package were 74,000 dpm/100 cm2 (decades per minute/100 centimeter squared). The package was placed in locked storage to prevent the spread of contamination. The common carrier was notified of the contaminated package.

AGREEMENT STATE REPORT - DAMAGED GAUGE

The following information was provided by the North Dakota Department of Environmental Quality (the Department) via email:

"On June 12, 2025, at 1647 MDT, the Department received a notification from Minn-Dak Farmers Cooperative reporting an equipment issue identified on June 11, 2025. The issue involved a fixed nuclear gauge (Thermo MeasureTech model 7063, S/N: 1519A), containing a 500 millicurie (original activity) Cs-137 sealed source. The Department is waiting for specific sealed source information.

"The facility is transitioning into a scheduled plant maintenance and cleaning downtime period. As part of this downtime, the radiation safety officer (RSO) planned to replace the referenced fixed gauge. During this process, it was discovered that the fixed tab used to secure the shutter arm in the locked-out position had broken off. Although the shutter mechanism remains operational, the gauge can no longer be properly locked out due to the missing tab.

"There is no visible damage to the source holder's structure or housing. The gauge continues to function securely in its installed position and does not present an operational safety concern.

"The last shutter check was in March 2025, and there was no indication of damage to the fixed gauge [at that time].

"No overexposures occurred during this event.

"Currently, the RSO is in contact with the vendor for plans to remove and dispose of the gauge and replace it with a new gauge.

"This is reported per 10 CFR 30.50(b)(2)."

ND Event Number: ND250002

MEDICAL EVENT

The following information was provided by the licensee via phone and email:

"On 6/12/25 four patients received intradermal administrations of 3 mCi Tc-99m mebrofenin (in three 1-mCi injections at the site) instead of the prescribed 3 mCi Tc-99m sulfur colloid (in three 1-mCi injections at the site) for sentinel lymph node biopsy.

"A physician detected an abnormality on imaging. One patient was also administered the correct (prescribed) dose of 3 mCi Tc-99m sulfur colloid before going to surgery. The other three patients had already gone to surgery when the abnormality was detected. The surgeon detected lymph node counts for two of the patients and resected the nodes (assumed successfully). The surgical status of the third patient is unknown; nuclear medicine will review the pathology results for all four patients when available and follow up accordingly.

"Since 6/12/25, nuclear medicine has been investigating the circumstances that led to dispensing an administration of the wrong radiopharmaceutical and evaluating the dosimetry implications of mebrofenin. Because mebrofenin is typically administered intravenously for liver and gallbladder studies, there is little or no published information on skin dose from intradermal administration. The authorized medical physicist (AMP) does not believe the shallow-dose equivalent (SDE) from 3 mCi intradermal mebrofenin would exceed the documented SDE from 3 mCi intradermal sulfur colloid (105 rad) due to the biokinetics of mebrofenin. Imaging suggests that it quickly migrated away from the injection site. However, on 6/19/25, the radiation safety officer (RSO), in consultation with nuclear medicine and the AMP concluded that the event should be reported to NRC as a potential medical event, because we cannot be certain that the SDE does not exceed 50 rad.

"All patients and their referring physicians have been notified. The authorized user physician does not expect any adverse effects as a result of the dosing error.

"The RSO will contact REAC/TS to determine if an accurate SDE can be calculated or derived for this event."

The licensee notified the NRC Region 3 project manager.

The following additional information was obtained from the licensee in accordance with Headquarters Operations Officers Report Guidance:

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.