BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    "3.5"TRIFURCATED EXTENSION SET WITH ROTATING MALE LUER LOCKS

    MDR report key: 1870414 · Received September 28, 2010

    Report

    Report Number
    1870414
    Event Type
    Malfunction
    Date Received
    September 28, 2010
    Date of Event
    July 8, 2010
    Report Date
    July 9, 2010
    Manufacturer
    CHURCHILL MEDICAL SYSTEMS
    Product Code
    FPA
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    FL, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    EXTENSION TUBING SEPARATED AT MANUFACTURER'S ATTACHED HUB WHILE INFUSING MEDICATIONS AND FLUIDS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 "3.5"TRIFURCATED EXTENSION SET WITH ROTATING MALE LUER LOCKS IV EXTENSION FPA CHURCHILL MEDICAL SYSTEMS AMS-887-4 1003103, 911079, 1006140

    Patients

    Seq Age Sex Outcome Treatment
    1 4 YR OTHER