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| Start date | Reporting criterion | Title | Event description | System | LER | |
|---|---|---|---|---|---|---|
| ENS 57200 | 27 June 2024 18:30:00 | Agreement State | Y-90 Underdose | The following information was received from the Massachusetts Radiation Control Program (the Agency) via email: On 06/28/24 at 1430 EDT, the licensee reported a medical event under license 60-0096 for BWXT Medical Ltd. TheraSpheres Model TheraSphere Y-90 Glass Microsphere System (Sealed Source and Device Registry: NR-0220-D-131-S) for total administered activity that differed from prescribed treatment activity as documented in the written directive by 20 percent or more. The medical event was reported to the radiation safety officer (RSO) at 1430 EDT on 6/27/2024. The prescribed dose to the patient was 106.4 mCi over two fractions. The dose received by the patient was 68.5 mCi (60.4 mCi on the first fraction, and 8.1 mCi on the second fraction). This resulted in an under dose of 35.6 percent. The authorized user and prescribing physician have been notified. The licensee has not reported whether the patient has been notified. The Agency will follow up with licensee RSO to determine the event cause and corrective actions. The Agency considers this event open. The Agency will follow up with a special inspection of the licensee. 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. |