BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MERIT CUSTOM KIT

    MDR report key: 2040302 · Received February 15, 2011

    Report

    Report Number
    1721504-2011-00096
    Event Type
    Malfunction
    Date Received
    February 15, 2011
    Date of Event
    February 2, 2011
    Report Date
    February 18, 2011
    Manufacturer
    MERIT MEDICAL SYSTEMS, INC.
    Product Code
    DTL
    PMA / PMN Number
    K934123
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE SUSPECT DEVICE WILL NOT BE RETURNED FOR EVALUATION. THE CUSTOMER DISPOSED OF THE DEVICE. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE INVESTIGATION HAS BEEN COMPLETED. CONCLUSIONS: A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE INVESTIGATION HAS BEEN COMPLETED.

    Description of Event or Problem · 1

    DURING A LEFT VENTRICULOGRAM, THE ROTATOR ON THE STOPCOCK BROKE. NO HARM OR INJURY WAS REPORTED. THE CUSTOMER REPORTED, TWO DEFECTIVE DEVICES BUT DID NOT PROVIDE ANY FURTHER INFORMATION OR CLINICAL DETAILS ABOUT THE ADDITIONAL EVENT. THEREFORE, THIS SINGLE FORM FDA 3500A WILL BE SUBMITTED FOR THIS COMPLAINT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MERIT CUSTOM KIT CATHETER, INTRAVASCULAR, DIAGNOSTIC DTL MERIT MEDICAL SYSTEMS, INC. F739767

    Patients

    Seq Age Sex Outcome Treatment
    1 CONTRAST MEDIA