BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FLOLINK

    MDR report key: 2222020 · Received August 19, 2011

    Report

    Report Number
    MW5021814
    Event Type
    Malfunction
    Date Received
    August 19, 2011
    Date of Event
    August 17, 2011
    Report Date
    August 18, 2011
    Manufacturer
    BAXTER HEALTHCARE CORP
    Product Code
    FPA
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CO, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    DISPLACEMENT DEVICE LUER ACTIVATED VALVE FOR IV ACCESS; PLASTIC FROM IV TUBING CRACKED OFF ON BLUE HUB. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FLOLINK POSITIVE DISPLACEMENT DEVICE LUER ACTIVATED VALVE FOR IV ACCESS FPA BAXTER HEALTHCARE CORP

    Patients

    Seq Age Sex Outcome Treatment
    1 86 YR