BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HIGH PRESSURE TUBING /K09-03750 CONVENIENCE KIT

    MDR report key: 1442922 · Received April 30, 2009

    Report

    Report Number
    1721504-2009-00063
    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
    FPK
    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, ALTHOUGH THE COMPLAINT COULD NOT BE DUPLICATED. DURING A PERFORMANCE TEST, THE TUBING WAS PRESSURIZED AND THE ROTATOR ASSEMBLY DID NOT LEAK OR SEPARATE. THESE TYPES OF COMPLAINTS WILL BE MONITORED FOR ANY INCREASING TRENDS.

    Description of Event or Problem · 1

    THE COMPLAINANT REPORTED HAVING PROBLEMS WITH THE ROTATOR HUB CONNECTED TO PRESSURE TUBING WITHIN THE CONVENIENCE KIT. SPECIFICALLY, THEY REPORTED THE ROTATING END IS BLOWING APART DURING INJECTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HIGH PRESSURE TUBING /K09-03750 CONVENIENCE KIT CATHETER, INTRAVASCULAR, DIAGNOSTIC FPK MERIT MEDICAL SYSTEMS, INC. NA

    Patients

    Seq Age Sex Outcome Treatment
    1