BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INSYTE AUTOGAURD IV CATHETER (BLUE 22GA X 1.00IN SAFETY)

    MDR report key: 1233006 · Received November 9, 2008

    Report

    Report Number
    1233006
    Event Type
    Malfunction
    Date Received
    November 9, 2008
    Date of Event
    September 29, 2008
    Report Date
    November 9, 2008
    Manufacturer
    BD INFUSION THERAPY SYSTEMS, INC.
    Product Code
    FOZ
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MI, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    WHILE STARTING A PERIPHERAL IV, THE NURSE NOTICED THAT THE FLUID WAS LEAKING FROM AROUND THE CONNECTION TO THE INSYTE HUB. THIS HAS HAPPENED AT LEAST ONE OTHER TIME RECENTLY TO ANOTHER NURSE. UPON INSPECTION OF THE RIM OF THE INSYTE, IT LOOKS AS IF THE LIP IS SLIGHTLY MELTED, NOT ALLOWING A TIGHT SEAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INSYTE AUTOGAURD IV CATHETER (BLUE 22GA X 1.00IN SAFETY) CATHETER, IV FOZ BD INFUSION THERAPY SYSTEMS, INC. * 8121957

    Patients

    Seq Age Sex Outcome Treatment
    1 *