BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MERIT CUSTOM KIT

    MDR report key: 3944075 · Received May 1, 2014

    Report

    Report Number
    1721504-2014-00088
    Event Type
    Malfunction
    Date Received
    May 1, 2014
    Date of Event
    April 3, 2014
    Report Date
    April 3, 2014
    Manufacturer
    MERIT MEDICAL SYSTEMS, INC.
    Product Code
    DQO
    PMA / PMN Number
    K994253
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION: ONE UNUSED SUSPECT DEVICE WAS RETURNED FOR EVALUATION. THE DEVICE HISTORY RECORD WAS REVIEWED AND NO EXCEPTION DOCUMENTS WERE FOUND. THE COMPLAINT DATABASE WAS REVIEWED AND ONE SIMILAR COMPLAINT FOR THIS LOT NUMBER WAS FOUND. THE DEVICE WAS EXAMINED VISUALLY, PARTICULATE LARGER THAN THE ACCEPTANCE CRITERIA WAS FOUND. THE COMPLAINT WAS CONFIRMED FOR THIS DEVICE. THE ROOT CAUSE IS ATTRIBUTED TO THE MANUFACTURING PROCESS. CORRECTIVE ACTION IS IN PROCESS.

    Description of Event or Problem · 1

    THE DISTRIBUTOR REPORTED THAT A FOREIGN OBJECT WAS IDENTIFIED IN THE BARREL OF THE SYRINGE 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
    262228 MERIT CUSTOM KIT CATHETER, INTRAVASCULAR, DIAGNOSTIC DQO MERIT MEDICAL SYSTEMS, INC. H568275

    Patients

    Seq Age Sex Outcome Treatment
    1