BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MERIT CUSTOM KIT

    MDR report key: 2800049 · Received October 17, 2012

    Report

    Report Number
    1721504-2012-00163
    Event Type
    Malfunction
    Date Received
    October 17, 2012
    Date of Event
    September 20, 2012
    Report Date
    September 20, 2012
    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 UN-OPENED DEVICE RETURNED FOR EVAL. THE EVAL IS IN PROCESS. A F/U REPORT WILL BE SUBMITTED WHEN THE EVAL HAS BEEN COMPLETED.

    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
    1 MERIT CUSTOM KIT CATHETER, INTRAVASCULAR, DIAGNOSTIC FMF MERIT MEDICAL SYSTEMS, INC. H385825

    Patients

    Seq Age Sex Outcome Treatment
    1