BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BAXTER HEALTHCARE CORP

    MDR report key: 345983 · Received August 7, 2001

    Report

    Report Number
    MW1022575
    Event Type
    Malfunction
    Date Received
    August 7, 2001
    Date of Event
    July 15, 2001
    Report Date
    July 27, 2001
    Manufacturer
    BAXTER HEALTHCARE CORP. MALLINC
    Product Code
    FPA
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    IV TUBING SETS X 3 NOTED TO HAVE DEFECT (HOLE) IN TUBING ADJACENT TO THE ROLLER CLAMP. NO ADVERSE EFFECT TO PTS; NOTED PRIOR TO USE ON PTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    35638 BAXTER HEALTHCARE CORP INTERLINK IV SOLUTION SET FPA BAXTER HEALTHCARE CORP. MALLINC 2C6425S UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 * Other