BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFE GUARD

    MDR report key: 2171299 · Received July 15, 2011

    Report

    Report Number
    MW5021407
    Event Type
    Malfunction
    Date Received
    July 15, 2011
    Date of Event
    June 29, 2011
    Report Date
    June 30, 2011
    Manufacturer
    CHURCHILL MEDICAL SYSTEMS
    Product Code
    FMI
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    OH, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    CHURCHILL MEDICAL SYSTEMS LIFE GUARD NON CORING SAFETY INFUSION SET PRODUCT CODE CLG 2010 20 GA X 1 INCH LEAKED WHEN NURSE ADMINISTERED SALINE THROUGH IT. NO PT HARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LIFE GUARD PORT NEEDLE FMI CHURCHILL MEDICAL SYSTEMS 1010028

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR