BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EXTENSION SET 7" MICROBORE

    MDR report key: 12705 · Received April 12, 1994

    Report

    Report Number
    MW1001564
    Event Type
    Injury
    Date Received
    April 12, 1994
    Date of Event
    March 18, 1994
    Report Date
    March 18, 1994
    Manufacturer
    CHURCHILL MEDICAL SYSTEMS, INC.
    Product Code
    FPA
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MN, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    HOME CARE PT RECEIVED 2 CDA (CHEMOTHERAPY) FOR 20 HRS WHEN LEAKING AT THE SITE WAS NOTED BY AN RN. THE EXTENSION TUBING WAS NOTED TO BE LEAKING BELOW THE HUB. THE LINE NEEDED UROKINASE TO CLEAR DUE TO THE HOLE IN THE EXTENSION TUBING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EXTENSION SET 7" MICROBORE EXTENSION SET 7" MICROBORE FPA CHURCHILL MEDICAL SYSTEMS, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 34 YR Required Intervention