BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RAPIDSTRAND

    MDR report key: 2221379 · Received July 22, 2011

    Report

    Report Number
    2915056-2011-00006
    Event Type
    Malfunction
    Date Received
    July 22, 2011
    Manufacturer
    ANAZAO HEALTH CORPORATION
    Product Code
    KXK
    PMA / PMN Number
    K063177
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    IN RESPONSE TO A PRIOR PRODUCT COMPLAINT, ALL ORDERS PROCESSED ON THE SAME DAY WERE REVIEWED. THIS REVIEW IDENTIFIED THE PROBABILITY THAT CALIBRATION STRANDS HAD BEEN SWAPPED BETWEEN ORDERS AND THE PRESENT REPORTER ADVISED ACCORDINGLY. EVAL SUMMARY: THE MFG FACILITY DETERMINED THAT A TECH HAD BROKEN STANDARD OPERATING PROCEDURE (SOP) BY LOADING TWO ORDERS SIMULTANEOUSLY AND THAT IN SO DOING HAD INADVERTENTLY SWITCHED THE CALIBRATION STRANDS BETWEEN THE ORDERS WHILE CORRECTLY LOADING THE THERAPY SEEDS INTO THE NEEDLES. CORRECTIVE ACTIONS COMPRISED (B)(4). SINCE THE THERAPY SEEDS WERE OF THE CORRECT ACTIVITY, AND SINCE THE FACILITY WAS ABLE TO PERFORM THE IMPLANTATION, THIS MALFUNCTION DID NOT CAUSE OR CONTRIBUTE TO AN ADVERSE PT OUTCOME. WERE A MALFUNCTION OF THIS TYPE TO RECUR (INCORRECT CALIBRATION STRAND ACTIVITY WITH IMPLANTATION SEEDS OF CORRECT ACTIVITY), THE MFR IS OF THE OPINION THAT IT WOULD NOT CAUSE OR CONTRIBUTE TO DEATH OR SERIOUS INJURY.

    Description of Event or Problem · 1

    ON (B)(6) 2011, RAPIDSTRAND IODINE (I-125) SEEDS MODEL 7000 LOT 82597952 WERE SUPPLIED TO A USER FACILITY FOR A BRACHYTHERAPY IMPLANT PROCEDURE. BEFORE IMPLANTATION, THE CALIBRATION STRAND WAS ASSAYED AND ACTIVITY FOUND TO DEVIATE FROM LABEL BY 8.3%. THE FACILITY DISASSEMBLED ONE NEEDLE FROM THE ORDER AND ASSAYED THE SEEDS THEREIN, FINDING THEM TO BE WITHIN 3.9% OF STATED ACTIVITY. BASED ON THIS THEY CONCLUDED THAT THE CALIBRATION STRAND WAS INCORRECT AND THAT THE SUPPLIED IMPLANTATION SEEDS WERE CORRECT. THE TREATMENT PLAN WAS ADJUSTED AND THE FACILITY PROCEEDED WITH THE IMPLANTATION WITHOUT INCIDENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RAPIDSTRAND BRACHYTHERAPY IMPLANT KXK ANAZAO HEALTH CORPORATION 7000 82597912

    Patients

    Seq Age Sex Outcome Treatment
    1