BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MERIT CUSTOM KIT

    MDR report key: 2961312 · Received February 8, 2013

    Report

    Report Number
    1721504-2013-00024
    Event Type
    Malfunction
    Date Received
    February 8, 2013
    Date of Event
    January 15, 2013
    Report Date
    January 15, 2013
    Manufacturer
    MERIT MEDICAL SYSTEMS, INC.
    Product Code
    FMF
    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 NEW, UNUSED DEVICE WAS RETURNED FOR EVAL. THE DEVICE HISTORY RECORD WAS REVIEWED AND FOUND NO EXCEPTION DOCUMENTS. THE COMPLAINT DATABASE WAS REVIEWED AND FOUND THREE 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 MANUFACTURING PROCESS.

    Description of Event or Problem · 1

    THE DISTRIBUTOR REPORTED CONTAMINATION 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
    55196 MERIT CUSTOM KIT CATHETER, INTRAVASCULAR, DIAGNOSTIC FMF MERIT MEDICAL SYSTEMS, INC. H391840

    Patients

    Seq Age Sex Outcome Treatment
    1