BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BRAUN

    MDR report key: 448744 · Received March 17, 2003

    Report

    Report Number
    MW1027882
    Event Type
    Malfunction
    Date Received
    March 17, 2003
    Date of Event
    March 14, 2003
    Report Date
    March 14, 2003
    Manufacturer
    B. BRUAN MEDICAL, INC.
    Product Code
    FPA
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CO, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    TUBING LEAKED AT SECONDARY (PIGGYBACK LINE CLOSEST TO IV BAG) INJECTION SITE BELOW BUFF CAP DURING IV INFUSION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BRAUN ULTRASITE ADD IT IV PRIMARY IV SET FPA B. BRUAN MEDICAL, INC. REF US 3485 060421697

    Patients

    Seq Age Sex Outcome Treatment
    1 35 YR Other