Description of Event or Problem · 1
ON (B)(6) 2011, A MALE PT WAS IMPLANTED WITH SEVENTY-SEVEN IODINE (I-125) SEEDS, MODEL 6711, EACH INTENDED TO BE 13.024 MBQ (0.325 MCI), TO A TOTAL RADIOACTIVELY OF 1.002 GBQ (27.104 MCI) FOR TREATMENT OF PROSTATIC CANCER. SEEDS WERE SUPPLIED AS PRE-LOADED NEEDLES. PRELIMINARY INVESTIGATION OF A PRODUCT COMPLAINT REC'D FROM ANOTHER FACILITY SHOWED THE POSSIBILITY THAT A MFG ERROR OCCURRED IN WHICH SEEDS WERE SWAPPED BETWEEN TWO ORDERS, RESULTING IN SEEDS OF THE INCORRECT ACTIVITY BEING IMPLANTED INTO THIS PT. THE SEEDS RETURNED FROM THE OTHER FACILITY WERE ANALYZED. RESULTS INDICATED THAT 30 INCORRECT SEEDS OF 16.613 MBQ (0.449 MCI) COULD HAVE BEEN SWITCHED INTO THE IMPLANT, RESULTING IN AN ESTIMATED INCREASE IN IMPLANTED RADIOACTIVITY TO 1.071 GBQ (28.964 MCI), I.E., APPROX 6.42% ABOVE PRESCRIBED DOSE. FINAL INVESTIGATION RESULTS ARE PENDING. ALL ACTIVITIES AS AT DATE OF IMPLANTATION; HOWEVER, EXPOSURE OF TISSUES OUTSIDE THE PROSTATE WOULD BE MINIMALLY AFFECTED. TO DATE, NO ADVERSE EFFECTS HAVE BEEN REPORTED. FINAL INVESTIGATION RESULTS ARE PENDING. ALL ACTIVITIES AS A DATE OF IMPLANTATION.