BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MERIT CUSTOM KIT

    MDR report key: 2013819 · Received February 4, 2011

    Report

    Report Number
    1721504-2011-00041
    Event Type
    Malfunction
    Date Received
    February 4, 2011
    Date of Event
    October 29, 2010
    Report Date
    January 13, 2011
    Manufacturer
    MERIT MEDICAL SYSTEMS, INC.
    Product Code
    DQO
    PMA / PMN Number
    K913682
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION: THE EVALUATION HAS NOT BEEN COMPLETED. A F/U REPORT WILL BE SUBMITTED WHEN THE EVALUATION HAS BEEN COMPLETED. EVALUATION: CONCLUSIONS: A F/U REPORT WILL BE SUBMITTED WHEN THE EVALUATION HAS BEEN COMPLETED.

    Description of Event or Problem · 1

    THE ROTATOR BROKE DURING A LEFT VENTRICULOGRAM. INJECTOR SETTINGS: FLOW: 11 ML/SEC, VOLUME: 33 CC, PRESSURE: 949 PSI. NO HARM OR INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MERIT CUSTOM KIT CATHETER, INTRAVASCULAR, DIAGNOSTIC DQO MERIT MEDICAL SYSTEMS, INC. F750168

    Patients

    Seq Age Sex Outcome Treatment
    1 4 FR PIGTAIL CATHETER| CONTRAST MEDIA