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| Start date | Reporting criterion | Title | Event description | System | LER | |
|---|---|---|---|---|---|---|
| ENS 55378 | 30 June 2021 04:00:00 | Agreement State | Lost I-125 Brachytherapy Seed | The following was received via email from the North Carolina Radiation Protection Section (NC RPS) via email: On 07/06/2021 at 1554 EDT (the licensee) Chief Diagnostic Medical Physicist emailed NC RPS about a lost Iodine-125 seed. Seeds are used for localization of non-palpable breast nodules. The event occurred on 06/30/2021 but was not reported to (the Chief Diagnostic Medical Physicist) until 07/06/2021. On 07/07/2021 North Carolina Inspections Supervisor forwarded the email to an Inspector for review. The seed was assayed on 06/09/2021 with an activity of 0.15 mCi. The event originated at Atrium Health Union, 600 Hospital Drive, Monroe, NC 28112 under license number 090-0739-1. The seed was identified by imaging at the Monroe Breast Center prior to shipment. Surveys of the transport container were also performed before it left the facility confirming the seed was present. Image was included with follow up email. Atrium Health Union nuclear medical staff used a Ludlum Mo. 14-C with GM pancake probe, serial number 73404, calibration due 07/28/2021. Survey of package exterior showed a reading of 0.05 mR/hr and less than 0.02 mR/hr at one meter. The package left the facility at 1347 EDT on 06/30/2021. A courier service is used to transport specimens. Charlotte-Mecklenburg Hospital Authority's Carolinas Medical Center (CMC) pathology lab received the package at 1525 EDT on 06/30/2021. CMC pathology lab staff failed to perform package survey at time of receipt. The specimen was removed from the transport case and radiographed using a Faxitron cabinet x-ray unit on 06/30/2021. At this point, pathology staff found that the seed was not present in the specimen tissue. Image was included with initial notification email. At this point, pathology staff did not follow established procedures to notify CMC Radiation Safety staff. On 07/06/2021 (the CMC) Radiation Safety Officer (RSO) was notified of the incident. Radiation Safety staff immediately went to the CMC pathology lab and surveyed the lab using a Ludlum Mo. 2241 with a NaI probe, serial number 217339. Surveying began at 0830 EDT on 07/06/2021. The transport container, all work areas, all biological waste containers, floor areas, counters, and all areas where the seed could be located were surveyed. All readings were at background radiation levels (<0.02 mR/hr) and seed was not located. Seed Information: Manufacturer: Best Medical Lot#: 52188A-6 Radiation Type: low E gamma emitter Activity: 0.15 mCi, assayed on 06/09/2021 Licensee identified multiple failures which lead to the incident, including: 1. Failure of pathology lab staff to carefully handle specimen. 2. Failure to notify RSO at initial finding of incident. 3. Failure of pathology lab to follow established procedures. 4. Receiving notification at such a later date greatly diminishes likelihood of finding lost seed. Licensee proposed several corrective actions to prevent reoccurrence, including: 1. All pathology staff on radiation program will receive refresher training. 2. CMC pathology will have more accountability regarding the handling of radioactive material. 3. All specimens containing radioactive material received from outside facilities must be received at CMC pathology lab prior to 1600 EDT. 4. Extra stickers and labels will be utilized to clearly identify specimens containing radioactive material. 5. CMC pathology lab will handle specimens with extreme caution due to small size of seeds. North Carolina Incident Number: NC210012 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 | ||
| ENS 44823 | 27 January 2009 05:00:00 | Agreement State | Agreement State Report - Medical Event | The following information was obtained from the State of North Carolina via facsimile: On January 27, 2009, a Therasphere (Y-90 microsphere) procedure was scheduled for a patient in Room 4, Special Procedures. The treatment was planned to deliver 110 Gy to the left lobe of the liver. The delivery apparatus was assembled according to manufacturer instructions, without incident. The treatment was initiated. During the first infusion, the Authorized User noticed fluid leakage at the outlet flow line and needle insertion at the source vial. The RSO was contacted. An attempt was made to continue the infusion. The liquid continued to leak at the outlet flow line and needle junction. No additional radioactivity was delivered to the patient. The procedure was terminated. Post procedure survey readings of the source vial indicated that approximately 65% of the intended radioactivity was delivered to the patient. This resulted in a dose of 70 Gy delivered to the left lobe of the liver. The Authorized User indicated that no adverse clinical symptoms are expected. This was the second treatment for this patient. The manufacturer (MDS Nordion) was notified of the device problem on 01/28/09. All liquid and contamination was contained by Radiation Safety personnel. A Medical Event may indicate potential problems in a medical facilities use of radioactive materials. It does not necessarily result in harm to the patient.
Notified that the event is documented by the North Carolina Radioactive Materials Branch as incident NC-09-11. Notified the R1DO (Gray) and FSME (McIntosh). |