BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    4-WAY LARGE BORE (LIPID RESISTANT) STOPCOCK

    MDR report key: 1053187 · Received May 13, 2008

    Report

    Report Number
    1053187
    Event Type
    Malfunction
    Date Received
    May 13, 2008
    Date of Event
    May 2, 2008
    Report Date
    May 13, 2008
    Manufacturer
    BAXTER HEALTHCARE CORPORATION
    Product Code
    FMG
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    WI, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    THE 3-WAY STOPCOCK WAS ATTACHED TO THE PATIENT'S INTRODUCER CENTRAL LINE AND WAS FOUND TO BE LEAKING FLUID. IT HAD 2 CRACKS ON THE BOTTOM OF THE STOPCOCK. STAFF REPORT PREVIOUS PROBLEMS WITH THIS MODEL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 4-WAY LARGE BORE (LIPID RESISTANT) STOPCOCK STOPCOCK, 3-WAY FMG BAXTER HEALTHCARE CORPORATION * 2C6204

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR