BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MERIT CUSTOM KIT

    MDR report key: 3823853 · Received February 21, 2014

    Report

    Report Number
    1721504-2014-00033
    Event Type
    Malfunction
    Date Received
    February 21, 2014
    Date of Event
    January 24, 2014
    Report Date
    January 24, 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. A REVIEW OF THE DEVICE HISTORY RECORD FOUND NO EXCEPTION DOCUMENTS. THE COMPLAINT DATABASE WAS REVIEWED AND FOUND ONE SIMILAR COMPLAINT FOR THIS LOT NUMBER. THE DEVICE WAS EXAMINED VISUALLY, PARTICULATE LARGER THAN THE ACCEPTANCE CRITERIA WAS FOUND. THE COMPLAINT IS 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
    109752 MERIT CUSTOM KIT CATHETER, INTRAVASCULAR, DIAGNOSTIC DQO MERIT MEDICAL SYSTEMS, INC. H531687

    Patients

    Seq Age Sex Outcome Treatment
    1