BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BAXTER

    MDR report key: 1003375 · Received February 22, 2008

    Report

    Report Number
    MW5005658
    Event Type
    Malfunction
    Date Received
    February 22, 2008
    Date of Event
    February 15, 2008
    Report Date
    February 22, 2008
    Product Code
    FPA
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    IL, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    A HOLE WAS FOUND IN THE TUBING BEFORE IT WAS USED ON ANY PT(S).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BAXTER SOLUTION SET WITH DOU-VENT SPIKE FPA

    Patients

    Seq Age Sex Outcome Treatment
    1 YR Other