BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PRO-MAG BIOPSY NEEDLE

    MDR report key: 2013527 · Received February 3, 2011

    Report

    Report Number
    1036710-2011-00002
    Event Type
    Malfunction
    Date Received
    February 3, 2011
    Date of Event
    January 4, 2011
    Report Date
    January 4, 2011
    Manufacturer
    ANGIOTECH, MEDICAL DEVICE TECHNOLOGIES
    Product Code
    KNW
    PMA / PMN Number
    K980226
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THREE DEVICES HAVE BEEN RETURNED TO OUR FACILITY FOR EVALUATION OF THE DEFECT REPORTED. THERE IS A HOLE IN THE POLY SIDE OF THE POUCH IN EACH OF THE POUCHES. THE HOLE IS LOCATED NEAR THE TOP OF THE POUCH AT THE EDGE OF THE SPACER CLIP . THE HOLE WOULD OCCUR IF THERE IS A HARD IMPACT TO THE SPACER CLIP DURING SHIPMENT TO THE CUSTOMER. OUR FACILITY IS WORKING ON A PROJECT TO PACKAGE THE PRODUCT IN A THICKER POUCH.

    Description of Event or Problem · 1

    THE POUCH IS DRILLED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PRO-MAG BIOPSY NEEDLE BIOPSY NEEDLE KNW ANGIOTECH, MEDICAL DEVICE TECHNOLOGIES 765114120 019321Z5

    Patients

    Seq Age Sex Outcome Treatment
    1 Other