BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BRACHYSOURCE IODINE - 125 SEEDS IN MICK CARTRIDGE

    MDR report key: 3960623 · Received June 20, 2014

    Report

    Report Number
    1018233-2014-00156
    Event Type
    Malfunction
    Date Received
    June 20, 2014
    Report Date
    May 30, 2014
    Manufacturer
    BARD BRACHYTHERAPY, INC.
    Product Code
    KXK
    PMA / PMN Number
    K093663
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NV, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION IS STILL IN PROGRESS. ONCE THE INVESTIGATION IS COMPLETE, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED UPON OPENING PACKAGE A HOLE WAS NOTED IN THE POUCH CONTAINING THE MICK CONTAINER COMPROMISING THE STERILE BARRIER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    363409 BRACHYSOURCE IODINE - 125 SEEDS IN MICK CARTRIDGE KXK BARD BRACHYTHERAPY, INC. NA 3BYE0028/BBYE0052

    Patients

    Seq Age Sex Outcome Treatment
    1