BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MEDFUSION HI-FLO

    MDR report key: 2212530 · Received August 2, 2011

    Report

    Report Number
    2212530
    Event Type
    Malfunction
    Date Received
    August 2, 2011
    Date of Event
    August 2, 2011
    Report Date
    August 2, 2011
    Manufacturer
    SMITHS MEDICAL ASD, INC
    Product Code
    FMG
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    VA, US

    Narratives

    Description of Event or Problem · 1

    WHEN FOUR WAY STOPCOCK WAS CONNECTED TO BD ANGIOCATH, IT WAS NOTED THAT IT WAS LEAKING FROM HUB (WHERE TUBING IS FUSED TO CONNECTOR). REPLACED WITH NO PATIENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MEDFUSION HI-FLO LARGE BORE 4-WAY STOPCOCK FMG SMITHS MEDICAL ASD, INC * 1960108

    Patients

    Seq Age Sex Outcome Treatment
    1 *