BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MONARCH INFLATION SYRINGE KIT

    MDR report key: 2040278 · Received February 15, 2011

    Report

    Report Number
    1721504-2011-00097
    Event Type
    Malfunction
    Date Received
    February 15, 2011
    Date of Event
    February 7, 2011
    Report Date
    February 18, 2011
    Manufacturer
    MERIT MEDICAL SYSTEMS, INC.
    Product Code
    DTL
    PMA / PMN Number
    K925419
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVAL: THE SUSPECT DEVICE HAS NOT BEEN RETURNED FOR EVAL. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE EVAL HAS BEEN COMPLETED. CONCLUSIONS: A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE EVAL HAS BEEN COMPLETED.

    Description of Event or Problem · 1

    AFTER AN ANGIOPLASTY PROCEDURE, BLOOD LEAKED FROM THE ROTATOR ON THE HEMOSTASIS VALVE. NO HARM OR INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MONARCH INFLATION SYRINGE KIT INJECTOR AND SYRINGE, ANGIOGRAPHIC DTL MERIT MEDICAL SYSTEMS, INC. F722332

    Patients

    Seq Age Sex Outcome Treatment
    1 ANGIOPLASTY BALLOON| CONTRAST MEDIA