BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MERIT CUSTOM KIT

    MDR report key: 2193613 · Received July 14, 2011

    Report

    Report Number
    1721504-2011-00224
    Event Type
    Malfunction
    Date Received
    July 14, 2011
    Date of Event
    June 21, 2011
    Report Date
    June 21, 2011
    Manufacturer
    MERIT MEDICAL SYSTEMS, INC.
    Product Code
    DQO
    PMA / PMN Number
    K913682
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVAL: THE SUSPECT DEVICE IS NOT EXPECTED TO BE RETURNED FOR EVAL. THE CUSTOMER DID NOT SPECIFY IF THIS WAS THE INITIAL USE OF THE DEVICE. A F/U REPORT WILL BE SUBMITTED IF NEW INFO BECOMES AVAILABLE. EVAL: CONCLUSIONS: A F/U REPORT WILL BE SUBMITTED IF NEW INFO BECOMES AVAILABLE.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT DURING A LEFT HEART CATHETERIZATION PROCEDURE AIR WAS DRAWN INTO THE CONTRAST LINE BELOW THE SPIKE. THIS OCCURRED WHEN THE CUSTOMER PULLED BACK ON THE SYRINGE IN THE KIT. NO AIR WAS INJECTED INTO THE PT. NO HARM OR INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MERIT CUSTOM KIT CATHETER, INTRAVASCULAR, DIAGNOSTIC DQO MERIT MEDICAL SYSTEMS, INC. H221708

    Patients

    Seq Age Sex Outcome Treatment
    1