BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARROWGARD BLUE PLUS MULTI-LUMEN CATHETER

    MDR report key: 3202309 · Received June 25, 2013

    Report

    Report Number
    MW5030721
    Event Type
    Malfunction
    Date Received
    June 25, 2013
    Date of Event
    June 22, 2013
    Report Date
    June 25, 2013
    Manufacturer
    ARROW
    Product Code
    DQO
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    FL, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PHYSICIAN AND RN REPORTED A PROBLEM WITH THREADING THE GUIDEWIRE THROUGH THE TRIPLE LUMEN CATHETER THAT THE PHYSICIAN WAS ATTEMPTING TO PUT INTO THE PT. THE PHYSICIAN DESCRIBED THAT THE GUIDEWIRE WOULD NOT THREAD FROM ONE END OF THE CATHETER TO THE OTHER AS IF THE LUMEN WAS NOT PATENT. THE PHYSICIAN REMOVED THE CATHETER FROM THE PT, OPENED ANOTHER KIT, AND WAS ABLE TO SUCCESSFULLY PLACE THE SECOND CATHETER. NO ADVERSE PT EVENTS OCCURRED AS A RESULT OF THE INCIDENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    287754 ARROWGARD BLUE PLUS MULTI-LUMEN CATHETER TRIPLE LUMEN CATHETER DQO ARROW CDC-45703-P1A RF3039951

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR