BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANGIOTECH BIOPINCE

    MDR report key: 3164111 · Received June 6, 2013

    Report

    Report Number
    3164111
    Event Type
    Malfunction
    Date Received
    June 6, 2013
    Date of Event
    June 4, 2013
    Report Date
    June 6, 2013
    Manufacturer
    MEDICAL DEVICE TECHNOLOGIES, INC.
    Product Code
    KNW
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    VA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    THE NEEDLE MISFIRED LEAVING A PIECE OF METAL "STICKING OUT" OF THE NEEDLE THEREBY PREVENTING THE NEEDLE FROM RETURNING TO THE GUIDE NEEDLE. NO SPECIMEN COULD BE OBTAINED WITH THIS DEVICE. THE PATIENT WAS NOT HARMED WITH THE DEVICE FAILURE. THE BIOPSY WAS OBTAINED UTILIZING A SECOND DEVICE.THIS IS THE THIRD SUCH DEVICE FAILURE WE HAVE EXPERIENCED IN THE PAST 30 DAYS.WHAT WAS THE ORIGINAL INTENDED PROCEDURE?MEDICAL RENAL BIOPSY.DEVICE #1IS THIS A LABORATORY DEVICE OR LABORATORY TEST?NO.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    252205 ANGIOTECH BIOPINCE INSTRUMENT, BIOPSY KNW MEDICAL DEVICE TECHNOLOGIES, INC. * 31192HCS

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR NO OTHER THERAPIES