BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MERIT CUSTOM KIT

    MDR report key: 3190492 · Received June 21, 2013

    Report

    Report Number
    1721504-2013-00138
    Event Type
    Malfunction
    Date Received
    June 21, 2013
    Date of Event
    May 29, 2013
    Report Date
    May 29, 2013
    Manufacturer
    MERIT MEDICAL SYSTEMS, INC.
    Product Code
    DQO
    PMA / PMN Number
    K994253
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVAL: ONE UNUSED SUSPECT DEVICE WAS RETURNED FOR EVAL. A REVIEW OF THE DEVICE HISTORY RECORD REVEALED THREE RELATED EXCEPTION DOCUMENTS. THE COMPLAINT DATABASE WAS REVIEWED AND FOUND FOUR SIMILAR DEVICE COMPLAINTS 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 MFG PROCESS. METHOD: ACTUAL DEVICE EVALUATED, VISUAL INSPECTION, PROCESS EVAL. RESULTS: DUST OR DIRT PROBLEM. CONCLUSIONS: MFG DEFICIENCY.

    Description of Event or Problem · 1

    THE DISTRIBUTOR REPORTED THAT A FOREIGN OBJECT WAS IDENTIFIED IN THE BARREL OF THE SYRINGE WITHIN 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
    282669 MERIT CUSTOM KIT CATHETER, INTRAVASCULAR, DIAGNOSTIC DQO MERIT MEDICAL SYSTEMS, INC. H441899

    Patients

    Seq Age Sex Outcome Treatment
    1