BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INSYTE AUTOGUARD

    MDR report key: 1951194 · Received December 20, 2010

    Report

    Report Number
    1951194
    Event Type
    Malfunction
    Date Received
    December 20, 2010
    Date of Event
    November 19, 2010
    Report Date
    December 20, 2010
    Manufacturer
    BD MEDICAL
    Product Code
    FOZ
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MI, US

    Narratives

    Description of Event or Problem · 1

    POKED PT FOR IV ACCESS AND INSERTED THE IV CATHETER WITH EASE. WHEN REMOVING THE INSERTER NEEDLE AND CANNULA, THE DEVICE WAS SLIGHTLY DIFFICULT TO REMOVE. DURING REMOVAL THE NEEDLE AND CANNULA SEPARATED AND THE NEEDLE PIERCED THE CANNULA. THE IV CANNULA WAS FOUND TO BE AROUND THE NEEDLE BUT NOT COMPLETELY COVERING IT. THE PT'S VEIN WAS BLOWN AND ACCESS WAS LOST.======================HEALTH PROFESSIONAL'S IMPRESSION======================TO CLARIFY WHEN A SITE IS BLOWN WE ARE SPEAKING OF THE VESSEL WALLS BEING COMPROMISED, LEAKING FLUID AND/OR BLOOD TO THE SURROUNDING TISSUE.YES, IN MY OPINION THE DEVICE FAILED. IT WOULD HAVE BEEN IMPOSSIBLE TO THREAD THE CANNULA INTO A VEIN IF IT WASN'T COMPLETELY SURROUNDING THE NEEDLE I INSERTED. ALSO, BECAUSE THE VEIN WAS ACCESSED COMPLETELY, IT WAS NO LONGER VIABLE AS AN IV SITE BECAUSE THE VESSEL WALLS WERE COMPRISED, LEAKING FLUID AND/OR BLOOD TO THE SURROUNDING TISSUE.======================MANUFACTURER RESPONSE FOR BD INSYTE-N AUTOGUARD ======================AWAITING RESPONSE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INSYTE AUTOGUARD CATHETER, INTRAVASCULAR, THERAPEUTIC, SHORT-TERM FOZ BD MEDICAL 381511 0196677

    Patients

    Seq Age Sex Outcome Treatment
    1 9 MO