BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEGUARD SAFETY INFUSION SET 20GA X 3/4"

    MDR report key: 2469923 · Received February 20, 2012

    Report

    Report Number
    2245270-2012-00010
    Event Type
    Malfunction
    Date Received
    February 20, 2012
    Date of Event
    January 9, 2012
    Report Date
    February 20, 2012
    Manufacturer
    VYGON CORP.
    Product Code
    FPA
    PMA / PMN Number
    K013871
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NE, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    FAILED SAMPLES WERE NOT RETURNED TO VYGON UNITED STATES, BUT THE CLINICIAN DID RETURN UN-OPENED SAMPLES FROM THE SAME LOT OF HUBER SETS. VYGON IS USING THESE UN-OPENED SAMPLES AS WELL AS INFORMATION FROM THE CLINICIAN TO PERFORM AN INVESTIGATION. A FOLLOW-UP MDR WILL BE SENT WITHIN THIRTY DAYS OF THE COMPLETION OF THE INVESTIGATION TO PROVIDE ADDITIONAL INFORMATION.

    Description of Event or Problem · 1

    AFTER THE INFUSION WAS COMPLETED THE CLINICIAN WAS UNABLE TO PULL THE WINGS UP TO ENGAGE THE SAFETY MECHANISM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LIFEGUARD SAFETY INFUSION SET 20GA X 3/4" SAFETY HUBER SET FPA VYGON CORP. CLG-2034 1110047

    Patients

    Seq Age Sex Outcome Treatment
    1