BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MERIT CUSTOM KIT

    MDR report key: 3944076 · Received May 1, 2014

    Report

    Report Number
    1721504-2014-00091
    Event Type
    Malfunction
    Date Received
    May 1, 2014
    Date of Event
    February 7, 2014
    Report Date
    February 7, 2014
    Manufacturer
    MERIT MEDICAL SYSTEMS, INC.
    Product Code
    DQO
    PMA / PMN Number
    K925419
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    ONE UNUSED DEVICE WAS RETURNED FOR EVALUATION. THE DEVICE HISTORY RECORD WAS REVIEWED AND NO EXCEPTION DOCUMENTS WERE FOUND. THE COMPLAINT DATABASE WAS REVIEWED AND NO SIMILAR COMPLAINTS FOR THIS LOT NUMBER WERE FOUND. DURING THE VISUAL INSPECTION, PERFORMED (B)(4) 2014, THE REPORTED EMBEDDED OBJECT WAS FOUND TO BE PARTICULATE IN THE FLUID PATH. THE PARTICULATE WAS LARGER THAN THE ACCEPTANCE CRITERIA. THE NEW FAILURE MODE WAS IDENTIFIED AND CONFIRMED FOR THIS DEVICE. THE ROOT CAUSE IS ATTRIBUTED TO THE MANUFACTURING PROCESS.

    Description of Event or Problem · 1

    THE DISTRIBUTOR REPORTED THAT AN EMBEDDED FOREIGN OBJECT WAS IDENTIFIED IN THE HEMOSTASIS VALVE INCLUDED IN THE KIT DURING THEIR INITIAL INSPECTION OF RECEIVED PRODUCT. THE DEVICE WAS NOT SENT TO A USER FACILITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    262227 MERIT CUSTOM KIT CATHETER, INTRAVASCULAR, DIAGNOSTIC DQO MERIT MEDICAL SYSTEMS, INC. H654621

    Patients

    Seq Age Sex Outcome Treatment
    1