BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MERIT CUSTOM KIT

    MDR report key: 3901609 · Received May 7, 2014

    Report

    Report Number
    1721504-2014-00096
    Event Type
    Malfunction
    Date Received
    May 7, 2014
    Date of Event
    April 15, 2014
    Report Date
    April 15, 2014
    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

    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. THE RETURNED DEVICE WAS EXAMINED AND THE COMPLAINT IS CONFIRMED. A COMPONENT WAS CAUGHT IN THE SEAL CREATING A BREACH. ROOT CAUSE IS ATTRIBUTED TO POOR PLACEMENT OF THE KIT WITHIN THE BLISTER ALLOWED THE CONNECTOR TO GET CAUGHT IN THE SEAL.

    Description of Event or Problem · 1

    THE DISTRIBUTOR REPORTED THAT A FEMALE CONNECTOR WAS CAUGHT IN THE PACKAGE SEAL. THIS RESULTED IN A HOLE IN THE TYVEK CAUSING A BREACH IN THE STERILE BARRIER. THIS WAS IDENTIFIED 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
    276072 MERIT CUSTOM KIT CATHER, INTRAVASCULAR, DIAGNOSTIC DQO MERIT MEDICAL SYSTEMS, INC. H579894

    Patients

    Seq Age Sex Outcome Treatment
    1