BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ULTRASITE OUTLOOK SAFETY INFUSION SYSTEM IV SET

    MDR report key: 1162965 · Received September 11, 2008

    Report

    Report Number
    1162965
    Event Type
    Malfunction
    Date Received
    September 11, 2008
    Date of Event
    September 11, 2008
    Report Date
    September 11, 2008
    Manufacturer
    B.BRAUN MEDICAL, INC.
    Product Code
    FPA
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CO, US

    Narratives

    Description of Event or Problem · 1

    RN REPORTS WHILE PRIMING TUBING IT WAS NOTED THERE WAS A SLICE IN THE TUBING. TUBING REMOVED, NEW TUBING OBTAINED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ULTRASITE OUTLOOK SAFETY INFUSION SYSTEM IV SET TUBING, IV FPA B.BRAUN MEDICAL, INC. * 0061002188

    Patients

    Seq Age Sex Outcome Treatment
    1 *