Event Notification Report for July 25, 2023

AGREEMENT STATE REPORT - LOST PACKAGE

The following information was provided by the Arkansas Department of Health, Radiation Control Section (the Department) via email:

"The Arkansas Department of Health, Radiation Control Section, was notified on July 7, 2023, via a phone call received from 3D Imaging Drug Design Development (3DI) in Little Rock, Arkansas, of a radioactive material package not ever reaching its intended destination (Canada). The package, when offered to the common carrier, contained 48.5 mCi of Zr-89 oxalate solution. Considering the half-life of 78.4 hours, the package contains approximately 2.5 mCi at the time of this report (July 17, 2023). The single, 3 mL glass vial was shipped within a 4-5 inch tall lead, cylindrical pig inside of a DOT Type A package, 1 cubic foot, 30 pounds, Yellow III.

"A second package of 12.9 mCi Zr-89 oxalate, was offered at the same time (July 3, 2023) to the same carrier but with a different destination (Maryland - also licensed for this type and quantity of material). The 3DI customer intended to receive the 48.5 mCi package instead received the second package with lesser activity. The 48.5 mCi package has not been located.

"3DI and the Department have been in communication with the carrier. The Department also contacted its NRC Regional State Agreement Officer who informed NRC Region I concerning the Maryland licensee and the NRC liaison for Canada concerning the Canadian licensee. The investigation is ongoing, and reporting will proceed in accordance with SA-300."

Arkansas Event #: AR-2023-005
Reporting requirement: RH-1501.a.1.B. of the ASBH Rules for Control of Sources of Ionizing Radiation [10 CFR 20.2201(a)(1)(ii)]

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 - ELUATE EXCEEDED Mo-99 LIMIT

The following information was provided by the Ohio Department of Health (ODH) via email:

Cardinal Health made a telephone notification [to ODH] on 7/17/2023 that a Lantheus Tc-99m generator, lot number M190311A, exceeded the Mo-99 breakthrough limits. The generator was eluted three times on 7/10/23. The results of the Mo-99 breakthrough test were 0.224, 0.313, and 1.705 microcuries Mo-99/millicurie Tc-99m. None of these elutions were used to dispense activity to customers or prepare drug kits. No doses containing Tc-99m from this generator were administered to patients. Lantheus was notified on 7/10/23, the generator was pulled, and a return kit was provided.

Ohio Incident Number: OH230008