BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BIOPINCE DISP. AUTO. BIOPSY INSTRUMENT

    MDR report key: 1733973 · Received June 9, 2010

    Report

    Report Number
    1036710-2010-00019
    Event Type
    Malfunction
    Date Received
    June 9, 2010
    Date of Event
    May 10, 2010
    Report Date
    May 10, 2010
    Manufacturer
    ANGIOTECH, MEDICAL DEVICE TECHNOLOGIES
    Product Code
    KNW
    PMA / PMN Number
    K904987A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS RETURNED AND INVESTIGATED. THIS DEVICE IS PACKAGED IN A FORMED BLISTER WITH A SEALED TYVEK LID. THERE IS A HOLE ON THE TYVEK SIDE OF THE PACKAGING. THE HOLE IS ABOVE THE HANDLE OF THE DEVICE AT THE LOCATION OF THE SAFETY LOCK. THE FLAP OF THE TYVEK IS FOLDED UNDER. A REVIEW OF COMPLAINTS FOR THE PAST 24 MONTHS FOUND NO RELATED COMPLAINTS. INTERNAL INVESTIGATION UNDER MAGNIFICATION CONCLUDED THAT THE TYVEK WAS DAMAGED FROM THE OUTSIDE AFTER PACKAGING. THE REMAINDER OF THE TYVEK IS INTACT.

    Description of Event or Problem · 1

    THERE IS A HOLE IN THE PACKAGING OF THE BIOPINCE DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BIOPINCE DISP. AUTO. BIOPSY INSTRUMENT BIOPSY INSTRUMENT KNW ANGIOTECH, MEDICAL DEVICE TECHNOLOGIES 360-1080-01 00201YYS

    Patients

    Seq Age Sex Outcome Treatment
    1 Other