BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PRO-MAG BIOPSY NEEDLE

    MDR report key: 1733974 · Received June 9, 2010

    Report

    Report Number
    1036710-2010-00020
    Event Type
    Malfunction
    Date Received
    June 9, 2010
    Date of Event
    May 18, 2010
    Report Date
    May 18, 2010
    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

    THE DEVICE SAMPLES WERE RETURNED AND EVALUATED. IT WAS NOTED THAT THE CANNULA HUB AND SHEATH MOVED INTO THE SPACER CLIP. THIS CAUSED THE STYLET TO EXTEND BEYOND THE SHEATH AND PUNCTURE THE POUCH DURING SHIPMENT TO THE CUSTOMER. A REVIEW OF PREVIOUS COMPLAINT WAS COMPLETED. THIS HAS OCCURRED TWICE PREVIOUSLY WITH A DIFFERENT PRODUCT. A REVIEW OF THE JOB ORDER WAS COMPLETED WITH NO DEFECTS OR DEVIATIONS NOTED. THIS DEFECT MAY OCCUR IF THE NOSE OF THE CANNULA HUB IS NOT PROPERLY LOCKED INTO PLACE WITH THE SPACER CLIP EDGE, OR THERE IS FORCE APPLIED TO THE NEEDLE OR PACKAGING TO CAUSE THE CANNULA TO MOVE UP INTO THE SPACER CLIP EXPOSING THE STYLET TIP. THE DEFECT IS READILY VISIBLE BY THE CUSTOMER.

    Description of Event or Problem · 1

    THERE IS A HOLE IN THE POUCH OF THE PRO-MAG DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PRO-MAG BIOPSY NEEDLE BIOPSY NEEDLE KNW ANGIOTECH, MEDICAL DEVICE TECHNOLOGIES 765018300 93421YB8

    Patients

    Seq Age Sex Outcome Treatment
    1 Other