BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MERIT CUSTOM KIT

    MDR report key: 3010856 · Received March 14, 2013

    Report

    Report Number
    1721504-2013-00059
    Event Type
    Malfunction
    Date Received
    March 14, 2013
    Date of Event
    February 15, 2013
    Report Date
    February 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 EVALUATION: ONE NEW UNUSED DEVICE WAS RETURNED FOR EVALUATION. THE EVALUATION IS IN PROCESS. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE EVALUATION HAS BEEN COMPLETED.

    Description of Event or Problem · 1

    THE DISTRIBUTOR REPORTED 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
    108301 MERIT CUSTOM KIT CATHETER, INTRAVASCULAR, DIAGNOSTIC FMF MERIT MEDICAL SYSTEMS, INC. H404011

    Patients

    Seq Age Sex Outcome Treatment
    1