BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ABBOTT "LIFESHIELD"

    MDR report key: 491520 · Received October 6, 2003

    Report

    Report Number
    MW1029812
    Event Type
    Malfunction
    Date Received
    October 6, 2003
    Date of Event
    October 1, 2003
    Report Date
    October 6, 2003
    Manufacturer
    ABBOTT LABORATORIES
    Product Code
    FPA
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MI, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PT HAD CARDIAC CATHETERIZATION AND 11,000 UNITS OF HEPARIN WERE GIVEN. ACTS FOLLOWING ADMINISTRATION WERE 143, 180, 134, 122. IV WAS FOUND LEAKING AT TWIN-SITE OPTION LOCK MALE ADAPTER. WHEN REMOVING EXTENSION SET, IT CAME APART IN 3 PIECES. NO APPARENT HARM TO PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ABBOTT "LIFESHIELD" TWIN SITE EXTENSION SET, 32 INCH FPA ABBOTT LABORATORIES 11959 03065 5H

    Patients

    Seq Age Sex Outcome Treatment
    1 84 YR