BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRIFURCATED EXTENSION SET

    MDR report key: 35046 · Received August 7, 1996

    Report

    Report Number
    MW1009663
    Event Type
    Malfunction
    Date Received
    August 7, 1996
    Date of Event
    August 1, 1996
    Report Date
    August 2, 1996
    Manufacturer
    CHURCHILL MEDICAL SYSTEMS, INC.
    Product Code
    FPA
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NE, US
    Reporter Occupation
    PHARMACIST

    Narratives

    Description of Event or Problem · 1

    THE LIPIDS FOR A NEONATE PT WOULD NOT FLOW DUE TO A DEFECT WITH THE SMALL BORE, THREE LEAD EXTENSION SET. AFTER REPLACING THE PUMP SET, IT WAS DISCOVERED THAT ONE OF THE LINES IN THE TRICONNECTOR WAS BLOCKED. ANOTHER SET WAS TRIED BY THE NURSE AND 2 LINES WERE BLOCKED IN IT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TRIFURCATED EXTENSION SET IV ADMINISTRATION SET FPA CHURCHILL MEDICAL SYSTEMS, INC. 40932, 41003, 51070, 51071

    Patients

    Seq Age Sex Outcome Treatment
    1 NO INFO