BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MERIT CUSTOM KIT

    MDR report key: 2272142 · Received September 13, 2011

    Report

    Report Number
    1721504-2011-00276
    Event Type
    Malfunction
    Date Received
    September 13, 2011
    Date of Event
    July 12, 2011
    Report Date
    August 19, 2011
    Manufacturer
    MERIT MEDICAL SYSTEMS, INC.
    Product Code
    DTL
    PMA / PMN Number
    K993057
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION: THE SUSPECT DEVICE HAS NOT BEEN RETURNED FOR EVALUATION. THE CUSTOMER DID NOT SPECIFY IF THIS WAS THE INITIAL USE OF THE DEVICE. THE CUSTOMER WAS UNSURE WHICH LOT NUMBER THE DEVICE CAME FROM. THE LOT NUMBER PRESENTED BELOW IS ANOTHER POSSIBLE LOT NUMBER PROVIDED BY THE CUSTOMER. H180552. EXPIRATION DATE: 10/31/2013. DEVICE MANUFACTURE DATE: 11/2010. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE EVALUATION HAS BEEN COMPLETED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE ROTATOR ON THE HEMOSTASIS VALVE BROKE WHILE MANIPULATING A GUIDING CATHETER. NO HARM OR INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MERIT CUSTOM KIT CATHETER, INTRAVASCULAR, DIAGNOSTIC DTL MERIT MEDICAL SYSTEMS, INC. H173255

    Patients

    Seq Age Sex Outcome Treatment
    1 GUIDING CATHETER: