BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MERIT CUSTOM KIT

    MDR report key: 4973305 · Received August 5, 2015

    Report

    Report Number
    1721504-2015-00141
    Event Type
    Malfunction
    Date Received
    August 5, 2015
    Date of Event
    July 13, 2015
    Report Date
    July 13, 2015
    Manufacturer
    MERIT MEDICAL SYSTEMS, INC
    Product Code
    DQO
    PMA / PMN Number
    K994253
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION: ONE UNUSED SUSPECT DEVICE WAS RETURNED FOR EVALUATION. THE DEVICE WAS EXAMINED VISUALLY, PARTICULATE LARGER THAN THE ACCEPTANCE CRITERIA WAS FOUND. THE COMPLAINT WAS CONFIRMED FOR THIS DEVICE. THE DEVICE HISTORY RECORD WAS REVIEWED AND NO RELATED EXCEPTION DOCUMENTS WERE FOUND. THE COMPLAINT DATABASE WAS REVIEWED AND NO RELATED COMPLAINTS FOR THIS LOT NUMBER WERE FOUND. THE ROOT CAUSE IS ATTRIBUTED TO THE MANUFACTURING PROCESS. A 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 VACUUM PRESSURE 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
    518681 MERIT CUSTOM KIT CUSTOM KIT DQO MERIT MEDICAL SYSTEMS, INC H778539

    Patients

    Seq Age Sex Outcome Treatment
    1