BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RAPIDSTRAND

    MDR report key: 2221377 · Received July 22, 2011

    Report

    Report Number
    2915056-2011-00005
    Event Type
    Malfunction
    Date Received
    July 22, 2011
    Date of Event
    April 1, 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

    EVAL SUMMARY: QA INVESTIGATION: SINCE THE PRODUCT WAS NOT RETURNED, DIRECT PHYSICAL EXAMINATION COULD NOT TAKE PLACE. A PHOTOGRAPH OF THE NEEDLE WAS SUPPLIED THAT SHOWED NO APPARENT DEFECTS IN THE NEEDLE TIP, STRAND, STYLET/NEEDLE LENGTH, OR EXCESSIVE BONEWAX. THE MFG UNIT COMMENTED THAT IT IS NOT INFREQUENT TO FIND A SPECIFIC NEEDLE DIFFICULT OR IMPOSSIBLE TO LOAD. ROOT CAUSE COULD THEREFORE NOT BE ESTABLISHED. CORRECTIVE ACTION WAS TAKEN TO RE-TRAIN TECHNICIANS WITH INSTRUCTIONS TO WITHDRAW FROM PRODUCTION NEEDLES THAT HAD RESISTANCE AND TO NOTIFY SITE QUALITY ASSURANCE OF THE NEEDLE LOT NUMBER FOR INVESTIGATION BY THE MFR.

    Description of Event or Problem · 1

    ON (B)(6) 2011, GE HEALTHCARE WAS ADVISED OF A MALFUNCTION CONCERNING A RAPIDSTRAND IMPLANTATION. DURING IMPLANTATION OF THE SEEDS, THE SEEDS STUCK IN THE END OF ONE OF THE NEEDLES AND WERE PULLED OUT OF THE PT, AS THE NEEDLE WAS WITHDRAWN. THE STRAND WAS INTACT AND HANGING FROM THE NEEDLE. THE FACILITY WAS ABLE TO RE-LOAD THE NEEDLE AND COMPLETE THE IMPLANTATION WITHOUT FURTHER INCIDENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RAPIDSTRAND BRACHYTHERAPY IMPLANT KXK ANAZAO HEALTH CORPORATION 7000 82583246

    Patients

    Seq Age Sex Outcome Treatment
    1