BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PERFORMA JUDKINS RIGHT CATHETER

    MDR report key: 1191099 · Received September 26, 2008

    Report

    Report Number
    1628221-2008-00021
    Event Type
    Malfunction
    Date Received
    September 26, 2008
    Date of Event
    August 28, 2008
    Report Date
    August 28, 2008
    Manufacturer
    MERIT MEDICAL SYSTEMS, INC.
    Product Code
    DQO
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    FIFTEEN UNUSED CATHETERS FROM THE SAME LOT AS THE SUSPECT DEVICES WERE RETURNED TO MERIT FOR EVALUATION. THE RETURNED UNITS WERE VISUALLY EXAMINED WITH NO DEFECTS BEING IDENTIFIED. TORQUE TESTS WERE PERFORMED AND THE CATHETERS PERFORMED WITHIN SPECIFICATIONS. THERE HAVE BEEN NO OTHER COMPLAINTS FILED FOR THIS LOT. NO RELEVANT ISSUES WERE IDENTIFIED IN THE DEVICE HISTORY RECORD. THE SUSPECT DEVICE WAS NOT RETURNED; THEREFORE, THE COMPLAINT COULD NOT BE CONFIRMED. EVAL: OTHER - COMPLAINT DATA REVIEWED, DEVICE HISTORY RECORD REVIEWED. RESULTS: OTHER - CATHETER.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DIAGNOSTIC CARDIOLOGY CATHETER WAS KINKING WHILE INSIDE THE BODY. THERE WAS NO HARM OR INJURY TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PERFORMA JUDKINS RIGHT CATHETER CATHETER, INTRAVASCULAR, DIAGNOSTIC DQO MERIT MEDICAL SYSTEMS, INC. NA G619206

    Patients

    Seq Age Sex Outcome Treatment
    1