BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARROWGARD BLUE

    MDR report key: 1122463 · Received August 1, 2008

    Report

    Report Number
    1122463
    Event Type
    Malfunction
    Date Received
    August 1, 2008
    Date of Event
    July 1, 2008
    Report Date
    July 25, 2008
    Manufacturer
    TELEFLEX MEDICAL
    Product Code
    DQO
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    TN, US

    Narratives

    Description of Event or Problem · 1

    PHYSICIAN WAS PLACING A RIGHT SUBCLAVIAN TRIPLE LUMEN CATHETER IN PATIENT. AFTER PHYSICIAN HAD PLACED CATHETER, SHE ATTEMPTED BUT WAS UNABLE TO DRAW BLOOD. THE PHYSICIAN STARTED WITHDRAWING THE CATHETER. AFTER WITHDRAWING TO DESIRED LEVEL, THE PHYSICIAN ATTEMPTED TO PLACE THE GUIDEWIRE BACK INTO THE CATHETER TO READVANCE THE CATHETER. PHYSICIAN THEN STATED THAT THE GUIDEWIRE WAS BENT. PHYSICIAN THEN WITHDREW THE CATHETER COMPLETELY FROM PATIENT'S SUBCLAVIAN AREA. UPON INSPECTION OF CATHETER, A SECTION WAS NOTED THAT WAS SHEARED OPEN. PATIENT WAS ASSESSED AND X-RAY COMPLETED TO SEE IF ANY OF THE CATHETER WAS IN PATIENT. NO FOREIGN OBJECTS WERE SEEN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ARROWGARD BLUE KIT, CENTRAL VENOUS CATHETER DQO TELEFLEX MEDICAL * RF7090509

    Patients

    Seq Age Sex Outcome Treatment
    1 25 YR