BEUDAMED
    FDA Adverse Event Summary report: N

    BECTON DICKINSON

    MDR report key: 2581344 · Received May 15, 2012

    Report

    Report Number
    MW5025423
    Date Received
    May 15, 2012
    Date of Event
    May 14, 2012
    Report Date
    May 15, 2012
    Product Code
    GES
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MN, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    THE OPERATING ROOM STAFF OPENED A TOTAL KNEE PACK AND FOUND #10 BLADES WITH BROWN CONTAMINATION. ALL THREE OF THE BLADES IN THE PACK WERE CONTAMINATED. IT WAS FOUND SUBSEQUENTLY THAT THERE WERE TWO MORE PACKS WHERE TO THE #10 BLADES IN THE TOTAL KNEE PACKS WERE CONTAMINATED, AND HAD A BLACK MATERIAL ON THEM. ALL THREE PACKS HAVE THE SAME LOT NUMBER ON THE #10 BLADE: 0003755. ALL #10 BLADES PULLED, AND BLADE REP CONTACTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BECTON DICKINSON SURGICAL BLADE #10 GES 0003755

    Patients

    Seq Age Sex Outcome Treatment
    1