BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CHURCHILL MED SYSTEMS INC

    MDR report key: 58391 · Received December 27, 1996

    Report

    Report Number
    58391
    Event Type
    Injury
    Date Received
    December 27, 1996
    Date of Event
    December 23, 1996
    Report Date
    December 24, 1996
    Manufacturer
    CHURCHILL MED SYSTEMS
    Product Code
    FPA
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    WA, US
    Reporter Occupation
    PHARMACIST

    Narratives

    Description of Event or Problem · 1

    PT'S MOTHER REPORTS LEAKING ARROUND THE AREA THAT THE TRIFURCATION OCCURS. IN-VITRO TEST ON PRODUCT IN OFFICE SHOWED SIMILAR LEAKAGE. PT WAS HOSPITALIZED FOR AN INFECTION SHORTLY AFTER LEAKAGE OCCURRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CHURCHILL MED SYSTEMS INC 7" TRIFURCATED EXT SET WITH COLOR CODED PINCH CLA FPA CHURCHILL MED SYSTEMS * 60347

    Patients

    Seq Age Sex Outcome Treatment
    1 5 YR Hospitalization TUBING CONNECTS TO A SINGLE LUMEN HICKMAN CATHETER