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 Start dateReporting criterionTitleEvent descriptionSystemLER
ENS 416662 May 2005 22:20:0010 CFR 35.3045(a)(1)Medical Event: Brachytherapy Under Dose AdministrationOn May 2, 2005 to May 3, 2005 during a planned 1 day 5 hour 22 minute brachytherapy vaginal dose a calculated 27% under dose of 1825 cGy dose was administered in a 2.5 cm solid vaginal cylinder. Two 19.56 mg Ra equivalent Cs-137 sources were used. This event was discovered on May 4, 2005 at 10 am, during a summary review, when the licensee discovered that the wrong size applicator cylinder was used. A 1.93 cm cylinder was planned to have been used to apply a 2500 cGy total dose. The licensee contacted the patient about the under dose and plans to administer the rest of the dose on May 5, 2005. The licensee is formulating a plan to administer additional training to the hospital staff to prevent future events of this type.
ENS 4087129 March 2004 06:00:0010 CFR 20.2201(a)(1)(ii)Shipment of Iodine-125 Implantation Seeds Found to Be One Seed Short of ExpectedOn 03/29/04, the licensee received a shipment of I-125 prostate implantation seeds (0.587 millicuries unshielded activity per seed) from the manufacturer, Amersham Biosciences of Chicago, IL. The shipment records indicated that 102 seeds were shipped. Upon receipt, the licensee performed an inventory of the shipment which confirmed that only 101 seeds were actually present (one of the pre-loaded cartridges contained 14 seeds rather than 15 as expected). The cartridges were still sealed and sterile-wrapped indicating that the missing seed was not the result of tampering or damage during shipment. Amersham replied to the licensee's inquiry on 05/21/04 indicating that their records indicated that the shipment did contain 102 seeds. Corrective actions for improved shipment accounting are being developed.