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 Entered dateEvent description
ENS 5514215 March 2021 12:43:00The following was received via an email from the state of North Carolina: Licensee reported that on March 11, 2021, a medical event occurred where the dose difference (from Iodine 131 is greater than 20 percent from the prescribed dosage). The prescribed dosage (by written directive) was 949 milliCuries; but the administered dose is estimated at this time to be about 507 milliCuries, which is 53% of the prescribed dose. The cause was a leaking tube from the infusion system. The bone marrow dose needed by the patient was considered sufficient, so there was no negative impact to the patient. An investigation by the North Carolina Radioactive Materials Branch is ongoing at this time. The radiopharmaceutical administered was Iomab-B (Iodine-131). North Carolina Tracking Number: 210003. 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.
ENS 5540917 August 2021 13:49:00The following information was obtained from the State of North Carolina via email: On 25 August 2020, an iodine-125 (I-125) seed was implanted into a perirectal mass in a patient for the purpose of localization and excisional biopsy. Following implantation, the Imaging team surveyed the needle and patient with a Geiger-Mueller detector per standard procedure to confirm proper placement of the seed within the mass. In addition, a post-implantation CT scan confirmed the presence of the seed within the mass. The seed and patient data were entered into the on-line 'Seed Tracker' software by the Imaging team per standard procedure. Excision of the tumor containing the seed was planned for the next day, and the patient was discharged home. At the time of surgery on 26 August 2020, the operative team was unable to detect the seed within the mass. Although the absence of the seed was documented in the operative note, the surgical team did not report that unusual occurrence to the Imaging team or the Radiation Safety Division. The specimen, which contained no seed and was not labeled as containing a seed, was sent to Surgical Pathology as a routine specimen and was processed as such. However, the Surgical Pathology team failed to notice that an entry for that patient and seed had been made in the 'Seed Tracker'. The error was not detected until an audit of the information in the 'Seed Tracker' was performed by staff of the Imaging teams and the Radiopharmacy in July 2021. The discrepancy between the 'Seed Tracker' data and the labeling and processing of the specimen as 'non-radioactive' was resolved when the surgical team's operative note was consulted. Because locating the seed would have been unlikely and impractical after 10 months (activity estimated to be 4 microcuries), our efforts were focused on investigating the root causes and identifying corrective actions. Probable disposition of lost material: Based upon the confirmation of seed placement in the perirectal mass by survey and CT scan, and its absence upon excision the following day, the seed most likely migrated out the implantation track and was discharged into the sanitary sewer during a bowel movement. Migration of seeds is uncommon but does occur. In this case, it would not have been noticed by the patient. North Carolina Item Number: NC210013 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