BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ABBOTT

    MDR report key: 12293 · Received February 3, 1994

    Report

    Report Number
    12293
    Event Type
    Malfunction
    Date Received
    February 3, 1994
    Date of Event
    January 4, 1994
    Report Date
    February 2, 1994
    Manufacturer
    ABBOTT LABORATORIES
    Product Code
    FPA
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    RN WAS ASSISTING PT INTO BED; T-PORT OF IV LOCK SEPARATED AT ITS CONNECTION (AT TUBING AND MALE ADAPTOR JUNCTION) CAUSING BLOOD TO BACK UP AND IV SYSTEM OPEN (POTENTIAL INFECTION AT ENTRY SITE).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ABBOTT EXTENSION SET FPA ABBOTT LABORATORIES 79-124-H1

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Other