Event Notification Report for June 02, 2015

MISSING IONIZERS

The following was excerpted from information received via facsimile:

"This letter follows up on an [initial] telephone report provided to the NRC Operations Center [at 1153 EDT] today pursuant to 10 CFR 20.2201(a)(i) regarding potentially missing NRC-regulated devices. During that call, Fabri-Form was asked to also submit [additional information] via facsimile to the NRC, providing information about the material contained in the devices, their serial numbers, and explaining how we became aware of the loss. Fabri-form is also submitting this letter pursuant to that request. We are also conducting an internal investigation into the matter and will submit a written report, as required under 10 CFR 20.2201(b), within 30 days.

"It appears that the potentially missing devices are six P-2021-8000 Ionizers, which are manufactured by NRD LLC. As we understand, these ionizers originally contained 10 mCi of polonium 210 and the serial numbers for the devices are A2FG071- 076.

"Fabri-Form became aware that it might possess NRC generally licensed devices on March 31, 2015, when it received a standard letter from the NRC's Office of Nuclear Material Safety and Safeguards, stating that the company possesses generally licensed devices subject to NRC oversight. The letter did not specify what those devices were and after internal inquiry, Fabri-Form was unable to determine what those devices were. Fabri-Form contacted Hector Rodriguez-Luccioni, the NRC contact listed in the letter [on 6/2/2015] and based on information provided by the manufacturer to the NRC, he was able to provide us with additional information, including what these devices were, the manufacturer, device serial numbers, and that their delivery date to Fabri-Form was August 2006. Fabri-Form also contacted the manufacturer yesterday, who confirmed the NRC's information. Fabri-Form has only one employee that has been with the company since 2006, and that individual was unable to recall specific details about these devices when we initially contacted them. Thus, after conversations with the NRC and NRD LLC yesterday, Fabri-Form first determined what these devices were and that they are potentially missing yesterday, and we promptly notified the NRC within 24 hours, as required under 10 CFR 20.2201(a)(i).

"Fabri-Form will continue to investigate this matter and detail the findings of our investigation in the required written report."

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 DUE TO MIS-ADMINISTRATION OF Y-90 SIR-SPHERES

The following information was received via E-mail:

"The Director of Radiology at Riverside Medical Center, Kankakee, IL called the Agency [Illinois Emergency Management Agency] to advise that a medical event had occurred during the administration of a Y-90 SIR-Sphere treatment on the morning of June 2, 2015. 35.2 mCi of Y-90 was intended to be delivered to the patient's liver to treat metastatic cancer lesions via the hepatic artery. However, when the patient was imaged immediately following the treatment, the kidney was observed as the organ which had received the dose with no material evident in the liver. It was determined that the infusion catheter was improperly placed. Instead of placement in the patient's hepatic artery, the renal artery was the infusion site. This was the facility's first patient to undergo this treatment modality. As a result, the manufacturer's proctor was present in addition to the treatment team members which included the radiologist, the radiation safety officer, the nuclear medicine technologist as well as others.

"The radiologist immediately informed the patient of the error while he was in post-op. As the facility had a second dose of Y-90 on hand of the same amount, and the patient consented, a second attempt was made that same afternoon where the infusion went as expected and the intended dose was delivered as originally planned to the liver with no complications.

"Although normally, an outpatient procedure, the patient was held overnight. Universal precautions were implemented throughout the time period and although the patient's sweat and saliva were not sources of contamination, the hospital managed the patient as they would an I-131 therapy patient and routine collection and measurement of the patient's urine was performed before discharge to the sewer system.. Radioactivity was confirmed as present in the urine when measured with a Geiger counter near the surface of the container. No other contamination was noted in the room. The patient was discharged the next day and follow up appointments are pending with the radiologist as well as a urologist.

"Dose estimates to the patient's kidney as a result of the event are being performed by the manufacturer as well as the medical center's consultant. The Agency is investigating this event and the licensee has been advised that a written report must be submitted per regulation."

Illinois Item Number: IL15013

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 - IRIDIUM 192 SOURCE LOST DURING SHIPMENT

The following was received from Florida via email:

"On 2 June 2015, an Ir-192 source was shipped via common carrier from Sand Lake Cancer Center in Orlando, Florida to Alpha-Omega Services [AOS] in Vinton, Louisiana. The common carrier states on the travel history that the source was unable to be shipped and was returning to the shipper. There is no date or time for the actual return, and no signature on file (as required). A representative from Elekta reported the 4.7Ci Ir-192 source missing on 17 February 2016 after receiving the information from Sand Lake. Sand Lake and AOS have been in contact between themselves and the common carrier and were unable to locate the source. [The Elekta representative] has already reported this incident to Georgia and is currently trying to get in touch with the common carrier RSO."

Florida incident #: FL16-032

* * * UPDATE PROVIDED BY KELLIE ANDERSON TO JEFF ROTTON AT 1136 EST ON 02/19/2016 * * *

The following information was provided via email:

Alpha-Omega Services reported to the State of Florida that the source has been located and it is in the Alpha-Omega Services offices in Vinton, LA where the source was being shipped to originally. I seems that it was an administrative error that caused the source to be reported as missing. The State of Florida considers incident # FL16-032 to be closed.

Notified the R1DO (Dentel), R4DO (Vasquez), and NMSS Events Notification Group via email.

THIS MATERIAL EVENT CONTAINS A "CATEGORY 3" LEVEL OF RADIOACTIVE MATERIAL

Category 3 sources, if not safely managed or securely protected, could cause permanent injury to a person who handled them, or were otherwise in contact with them, for some hours. It could possibly - although it is unlikely - be fatal to be close to this amount of unshielded radioactive material for a period of days to weeks. These sources are typically used in practices such as fixed industrial gauges involving high activity sources (for example: level gauges, dredger gauges, conveyor gauges and spinning pipe gauges) and well logging. For additional information go to http://www-pub.iaea.org/MTCD/publications/PDF/Pub1227_web.pdf