BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CHURCHILL MEDICAL SYSTEMS INC

    MDR report key: 140269 · Received December 29, 1997

    Report

    Report Number
    MW1012695
    Event Type
    Malfunction
    Date Received
    December 29, 1997
    Date of Event
    December 19, 1997
    Report Date
    December 22, 1997
    Manufacturer
    CHURCHILL MEDICAL SYSTEMS INC.
    Product Code
    FPA
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    VA, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    PT'S MOTHER CALLED AT 1:00 PM ON 12/19 TO NOTIFY RN THAT THE TUBING LEAKED WHEN HER HUSBAND INFUSED THE 12 NOON DOSE, OF IV ANTIBIOTIC. RN VISITED PT AND CHANGED EXTENSION TUBING DUE TO CRACK IN THE DISTAL END OF THE EXTENSION, WHERE LEUR LOCKS ONTO THE CAP. IN SPEAKING WITH RN WHO APPLIED THE EXTENSION, THEY STARTED "THE FIRST EXTENSION THEY PUT ON DID THE SAME THING, SO THEY CHANGED IT."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CHURCHILL MEDICAL SYSTEMS INC 7" MICROBORE NON-VENTED EXTENSION SET WITH MALE/FEMALE LEURL FPA CHURCHILL MEDICAL SYSTEMS INC. * 710037

    Patients

    Seq Age Sex Outcome Treatment
    1 22 MO