BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    B. BRAUN MEDICAL, INC.

    MDR report key: 511156 · Received February 4, 2004

    Report

    Report Number
    MW1031090
    Event Type
    Malfunction
    Date Received
    February 4, 2004
    Date of Event
    January 19, 2004
    Report Date
    January 21, 2004
    Manufacturer
    LEVENTON
    Product Code
    FPA
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    AZ, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    RATE FLOW REGULATOR WITH IV EXTENSION SET LEAKING AT CONNECTION ON TUBING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 B. BRAUN MEDICAL, INC. IV EXTENSION SET WITH RATE FLOW REGULATOR FPA LEVENTON * 30747L

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR