BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ULTRASITE (OUTLOOK SAFETY INFUSION SYSTEM IV SET)

    MDR report key: 1211645 · Received October 20, 2008

    Report

    Report Number
    1211645
    Event Type
    Malfunction
    Date Received
    October 20, 2008
    Date of Event
    October 14, 2008
    Report Date
    October 20, 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 THAT WHILE PRIMING IV TUBING, IT WAS NOTED THERE WAS A SLICE IN THE TUBING. IT WAS THEN REPLACED WITH NEW TUBING.

    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. 470042 0061002188

    Patients

    Seq Age Sex Outcome Treatment
    1 *