BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MANIFOLD IN K09-03750 CONVENIENCE KIT

    MDR report key: 1442919 · Received April 30, 2009

    Report

    Report Number
    1721504-2009-00066
    Event Type
    Malfunction
    Date Received
    April 30, 2009
    Date of Event
    March 31, 2009
    Report Date
    March 31, 2009
    Manufacturer
    MERIT MEDICAL SYSTEMS, INC.
    Product Code
    DTL
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION: THE SUSPECT DEVICE WAS RETURNED FOR EVALUATION. THE DEVICE WAS EXAMINED, AND THE COMPLAINT WAS VERIFIED. THE HANDLE STOPS OF THE MANIFOLD BODY HAD BEEN DAMAGED. THE MANIFOLD WAS COMPRESSED WITH CHANNEL LOCKS FOR SIGNS OF BRITTLENESS AT THE LUER OR BORE AND NONE WERE FOUND. THE ROOT CAUSE OF THE FAILURE COULD NOT BE DETERMINED. THESE TYPES OF COMPLAINTS WILL BE MONITORED FOR ANY INCREASING TRENDS. NO CONCLUSION CAN BE DRAWN.

    Description of Event or Problem · 1

    THE COMPLAINANT REPORTED HAVING PROBLEMS WITH THE MANIFOLD IN THE CONVENIENCE KIT. SPECIFICALLY, THEY REPORTED THE HANDLES ARE TURNING MORE THAN 180 DEGREES. THIS CAUSES COMPLICATION WITH PRESSURE READING AND INJECTING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MANIFOLD IN K09-03750 CONVENIENCE KIT CATHETER, INTRAVASCULAR, DIAGNOSTIC DTL MERIT MEDICAL SYSTEMS, INC. NA

    Patients

    Seq Age Sex Outcome Treatment
    1