BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEGUARD NON-CORIGN SAFETY INFUSION SET

    MDR report key: 2479438 · Received January 4, 2012

    Report

    Report Number
    2479438
    Event Type
    Malfunction
    Date Received
    January 4, 2012
    Date of Event
    January 3, 2012
    Report Date
    January 4, 2012
    Manufacturer
    CHURCHILL MEDICAL SYSTEMS, INC.
    Product Code
    FMI
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    RI, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    WHEN DE-ACCESSING PATIENT'S PAC, HUBER NEEDLE BROKE IN TWO PIECES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LIFEGUARD NON-CORIGN SAFETY INFUSION SET HUBER NEEDLE FMI CHURCHILL MEDICAL SYSTEMS, INC. CLG 2234 1109007

    Patients

    Seq Age Sex Outcome Treatment
    1 35 YR