BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BEAVER ARTHRO-LOK BANANA

    MDR report key: 2781996 · Received September 27, 2012

    Report

    Report Number
    2781996
    Event Type
    Malfunction
    Date Received
    September 27, 2012
    Date of Event
    November 15, 2011
    Report Date
    September 27, 2012
    Manufacturer
    BECTON DICKINSON
    Product Code
    GES
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    AZ, US

    Narratives

    Description of Event or Problem · 1

    DURING THE PROCEDURE, THE BLADE BROKE INTO THE PATIENT. THE BROKEN END WAS RETRIEVED. A SECOND BLADE WAS USED TO COMPLETE THE PROCEDURE WITHOUT INCIDENT. IT IS UNKNOWN IF THE SECOND BLADE WAS OF THE SAME OR DIFFERENT LOT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BEAVER ARTHRO-LOK BANANA BLADE, SCALPEL GES BECTON DICKINSON * 302388

    Patients

    Seq Age Sex Outcome Treatment
    1 42 YR