BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MERIT CUSTOM KIT

    MDR report key: 3101616 · Received May 3, 2013

    Report

    Report Number
    1721504-2013-00099
    Event Type
    Malfunction
    Date Received
    May 3, 2013
    Date of Event
    April 8, 2013
    Report Date
    April 8, 2013
    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 EVAL: THE EVAL HAS NOT BEEN COMPLETED. A F/U REPORT WILL BE SUBMITTED WHEN THE EVAL HAS BEEN COMPLETED.

    Description of Event or Problem · 1

    THE DISTRIBUTOR REPORTED THEY IDENTIFIED A SHARP CREASE AND CREEP IN THE POUCH THAT MAY LEAD TO A BREACH IN THE SEAL 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
    194973 MERIT CUSTOM KIT CATHETER, INTRAVASCULAR, DIAGNOSTIC DQO MERIT MEDICAL SYSTEMS, INC. H443170

    Patients

    Seq Age Sex Outcome Treatment
    1