BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BAXTER EMB 40

    MDR report key: 300081 · Received October 4, 2000

    Report

    Report Number
    MW1020133
    Event Type
    Malfunction
    Date Received
    October 4, 2000
    Date of Event
    September 26, 2000
    Report Date
    October 4, 2000
    Manufacturer
    BAXTER HEALTHCARE CO.
    Product Code
    DXE
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    VA, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    TIP OF FOGARTY CATHETER CAME OFF IN PT AS IT WAS BEING USED. PROBLEM WITH 3 CATH DIFFERENT LOT NUMBERS. NOT SURE WHICH ONE TIP CAME OFF OF: 510EC008 - LOT# EXP 2002-8, 510GC746 - LOT# EXP 2002-10, 510FC393 - LOT# EXP 2002-10.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BAXTER EMB 40 FOGARTY EMB 40 CATHETER DXE BAXTER HEALTHCARE CO. 120404F / 4F 510FC393, 510EC008, 510GC746

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Other