BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ULTRASITE OUTLOOK (SAFETY INFUSION SYSTEM IV SET)

    MDR report key: 1182844 · Received September 24, 2008

    Report

    Report Number
    1182844
    Event Type
    Malfunction
    Date Received
    September 24, 2008
    Date of Event
    September 18, 2008
    Report Date
    September 24, 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 IV, THE TUBING FELL APART. IT DISCONNECTED AT THE INFUSION PORT JUST BELOW THE BACKCHECK VALVE.WE HAVE BEEN WORKING WITH THE MANUFACTURER REGARDING THESE TUBING ISSUES. THEY ARE WORKING ON A SOLUTION.

    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 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 *