BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD INSYTE AUTOGUARD

    MDR report key: 1162943 · Received September 5, 2008

    Report

    Report Number
    1162943
    Event Type
    Malfunction
    Date Received
    September 5, 2008
    Date of Event
    August 15, 2008
    Report Date
    September 5, 2008
    Manufacturer
    BECTON DICKINSON
    Product Code
    FOZ
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    WI, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    WHEN INSERTED INTO THE PATIENT'S VEIN, THE CATHETER DID NOT SLIDE OFF THE NEEDLE AS EXPECTED, SO IT DID NOT SEAT PROPERLY IN THE VEIN. THE NEEDLE RETRACTED AS EXPECTED, BUT THE CATHETER DID NOT ADVANCE, AND HAD TO BE REPLACED. PATIENT WAS NOT HARMED, BUT HAD AN ADDITIONAL VENIPUNCTURE AS A RESULT. WE HAVE HAD 3 PRIOR INSTANCES OF CATHETERS NOT WORKING PROPERLY, AND HAVE PULLED ALL DEVICES OF THIS LOT # AND ARE REQUESTING REPLACEMENT PRODUCT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BD INSYTE AUTOGUARD CATHETER, IV, SAFETY FOZ BECTON DICKINSON 20 GA 1.00IN 8116575

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR