BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD

    MDR report key: 2171292 · Received July 13, 2011

    Report

    Report Number
    MW5021398
    Event Type
    Malfunction
    Date Received
    July 13, 2011
    Date of Event
    July 13, 2011
    Report Date
    July 13, 2011
    Manufacturer
    BECTON DICKINSON INFUSION THERAPY SYSTEMS, INC.
    Product Code
    FOZ
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    AR, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE MEDICAL CTR DISCOVERED A STERILE PACKAGED 20 GAUGE INTRAVENOUS CATHETER HAD APPARENT CONTAMINATES WITHIN THE SEALED PACKAGING. THE ITEM PACKAGE WAS NOTED TO BE INTACT BY STAFF, BUT THE APPARENT CONTAMINATE COULD BE SEEN THROUGH THE PACKAGING. TIME OF EVENT WAS APPROX 08:53 AM ON THIS DATE OF REPORT. THE MEDICAL CTR IMMEDIATELY REMOVED BD INSYTE AUTOGUARD WINGED 20GA 1.16 INCH CATHETER, LOT NUMBER 1066711 FROM OUR INVENTORY. INVENTORY STAFF ALSO EXAMINED OTHER STOCK WITH DIFFERENT LOT NUMBERS AS WELL AS SIMILAR ITEMS FROM THIS MFR. NO ADD'L INSTANCES WERE FOUND.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BD BD INSYTE AUTOGUARD WINGED 20 GA CATHETER FOZ BECTON DICKINSON INFUSION THERAPY SYSTEMS, INC. 1066711

    Patients

    Seq Age Sex Outcome Treatment
    1