BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARROW RADIAL ARTERY CATHETERIZATION SET

    MDR report key: 3119976 · Received May 10, 2013

    Report

    Report Number
    3119976
    Event Type
    Malfunction
    Date Received
    May 10, 2013
    Date of Event
    March 27, 2013
    Report Date
    May 7, 2013
    Manufacturer
    TELEFLEX INC.
    Product Code
    DQY
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MI, US

    Narratives

    Description of Event or Problem · 1

    A 20 GAUGE ARROW CATHETER SET WAS USED TO CANNULATE THE PATIENT'S RIGHT RADIAL ARTERY. ONCE THE ARTERY WAS CANNULATED THE WHITE CATHETER WAS THREADED INTO THE ARTERY. UNFORTUNATELY THE CATHETER END WAS MOSTLY OCCLUDED WITH WHITE PLASTIC (MANUFACTURED INCORRECTLY) SUCH THAT THE ARTERIAL LINE TUBING COULD NOT BE ATTACHED TO THE CATHETER END. THIS RESULTED IN UNNECCESSARY BLEEDING WHILE ADDITIONAL EQUIPMENT WAS BEING LOCATED AND WHILE TROUBLESHOOTING WAS TAKING PLACE. ONCE THE PROBLEM WAS IDENTIFIED A NEW CATHETER HAD TO BE PLACED INTO THE RADIAL ARTERY VIA A GUIDE WIRE. AND THEN THE NEW CATHETER WAS SUCCESSFULLY CONNECTED TO THE ARTERIAL LINE TUBING.WHAT WAS THE ORIGINAL INTENDED PROCEDURE?ARTERIAL CATHETERIZATION.DEVICE #1IS THIS A LABORATORY DEVICE OR LABORATORY TEST?NO.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    205230 ARROW RADIAL ARTERY CATHETERIZATION SET RADIAL ARTERY CATHETERIZATION SET DQY TELEFLEX INC. N/A CF2125391

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR