BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ABBOTT

    MDR report key: 484028 · Received August 26, 2003

    Report

    Report Number
    MW1029496
    Event Type
    Malfunction
    Date Received
    August 26, 2003
    Date of Event
    August 6, 2003
    Report Date
    August 15, 2003
    Manufacturer
    *
    Product Code
    FPA
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MO, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    TWO INCIDENTS THIS WK. FOUND PTS. WITH EPIDURAL CATHETER INTACT, BUT CONNECTOR TUBING PULLED APART AT DISTAL (CLOSEST TO PT) CONNECTOR. (TUBING PULLED OUT OF CONNECTOR). TUBING WAS CHANGED AS SOON AS POSSIBLE AFTER NOTICED. NO ADVERSE EFFECTS. PHARMACY NOTIFIED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ABBOTT LATEX FREE PUMP SET FPA * 13626 95079

    Patients

    Seq Age Sex Outcome Treatment
    1 * Other