Event Notification Report for December 23, 2025

PACKAGE SURFACE CONTAMINATION EXCEEDS LIMIT

The following information was provided by the licensee via phone:

The licensee received three packages of Lu-177 from their vendor. One of the packages was found to have surface contamination of 82,019 dpm/300 cm^2 (273 dpm/cm^2), in excess of the 10 CFR 71.87 limit of 240 dpm/cm^2. After the licensee confirmed that the contamination was not spread to other areas, the contents were unloaded and the packaging placed in their storage area to decay.

The vendor and delivery company have been notified.

* * * RETRACTION ON 12/15/2025 AT 1208 EST FROM CAMI STILL TO ERNEST WEST * * *

The following information was provided by the licensee via phone:

Additional testing was conducted, and it was determined that the radioactivity detected was pre-existing on the wipe used to obtain a smear of the package. There was no contamination that originated from the package. Any contamination on the wipe was confined to the hot lab.

Notified R3DO (Orlikowski) and NMSS Events Notification (email)

AGREEMENT STATE REPORT - MEDICAL EVENT

The following information was provided by the PA Bureau of Radiation Protection (the Department) via email:

"On December 12, 2025, a patient was receiving a Y-90 TheraSphere treatment. The prescribed dose was 131.08 mCi. The patient received a dose of 72.4 mCi. No effect on the patient occurred.

"It is suspected that the cause was either the use of a third-party administration tubing set or a microcatheter defect, that caused a delay in administration leading to a clog in the line. The official cause is still under investigation.

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

PA event report ID number: PA250018

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 ON 12/19/25 AT 1112 EST FROM JOHN CHIPPO TO KAREN COTTON * * *

The following additional information was provided by the PA Bureau of Radiation Protection (the Department) via email:

"On December 12, 2025, a patient was receiving 2 doses of Y-90 TheraSphere to 2 treatment sites. The prescribed dose was 131.08 mCi. The administration set was connected using the Boston Scientific checklist and all pre-checks, flushes, and priming were satisfactory with proper flow confirmed for the delivery kit and microcatheter. Issues developed as the first (larger) dose delivery initiated including leakage at the C-line, increased pressure, and excessive saline diversion to the pressure release vial. The RADOS dosimeter reduced by 93 percent, suggesting successful administration, however, subsequent 4-point measurements indicated a dose delivery of only 60.8 percent. It was determined that a 44.7 percent deviation between prescribed and administered dose occurred. The second smaller dose displayed the same issues with leakage and excess saline diversion but was administered with greater than 90 percent delivery. The patient received a dose of 72.4 mCi. The referring physician and the patient were notified. There was no adverse impact to the patient.

"It is suspected that the cause was the use of defective backup administration kits made by B. Braun, which were provided by Boston Scientific when the normal kits used at Thomas Jefferson University Hospital were unavailable due to backorder. The authorized user observed problems from the start of the administration including C-line clamp failure (requiring a hemostat to correct), increased pressure, and excess saline backflow to the pressure relief vial. An eventual obstruction occurred downstream after the dose vial and before the microcatheter, likely the clamp area between points 'D' and 'E' in the tubing. A high exposure rate was observed at this location (3.7 R/hr) while examining the waste materials supporting this location as having the obstruction. No other locations had exposure rates anywhere near this high.

"A second dose was administered to the same patient to a different treatment site in the liver using a fresh backup administration kit and the problem with the failed C-clamp and increased saline backflow repeated. In this case the dose was successfully delivered, likely because it was a much smaller dose (less beads, less chance of clumping up and obstructing the line in an environment of abnormal flow dynamics).

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

Notified R1DO (Carfang) and NMSS Events Notification (Email)

AGREEMENT STATE REPORT - LOST RADIOPHARMACEUTICALS

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

"The Agency was contacted by GE Healthcare in Arlington Heights, IL to advise of a diagnostic radiopharmaceutical package lost in transit.

"The package contained one vial of In-111 oxyquinoline, with an activity of 3.2 mCi. It was shipped from the licensee's facility on Friday, November 14, 2025, for delivery to RLS USA, Inc. of Trevose, PA. The last tracking information has documented receipt at the [common carrier's] sort facility on Saturday, November 15, 2025, at 0100 CST. Although there were several conversations with [the common carrier] on the location of the package, communication today has confirmed that the package cannot be located. In addition, the customer has acknowledged that the package was never received.

"The package has currently decayed to less than 280 nanocuries and does not represent a public health hazard. There is no indication of intentional theft/diversion, nor that the contents have been separated from the packaging."

Illinois item number: IL250051

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

LOST FILL-LEVEL GAUGES

The following information was provided by the licensee via phone:

While performing a full asset audit, the licensee was unable to locate two generally licensed Industrial Dynamics model SP-50B/PL fill-level gauges each containing a 100 mCi Am-241 source. The specific date of the last inventory at the licensee's facility is unknown but estimated to be within the past five years.

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