BEUDAMED
    FDA Adverse Event Other Summary report: N

    VORTEX-AC WITH KIT

    MDR report key: 1215657 · Received October 20, 2008

    Report

    Report Number
    1056436-2007-00083
    Event Type
    Other
    Date Received
    October 20, 2008
    Date of Event
    February 26, 2007
    Report Date
    October 15, 2008
    Manufacturer
    ANGIODYNAMICS, INC.
    Product Code
    LJT
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPLAINT WAS NOT CONFIRMED. NO AIR BUBBLES WERE OBSERVED WHEN THE DEVICE WAS FLUSHED/ASPIRATED IN THE LABORATORY SETTING. THE CAUSE OF THE AIR BUBBLES OBSERVED IN THE CLINICAL SETTING MAY HAVE BEEN DUE TO THE CATHETER/PORT CONNECTION AND/OR THE CATHETER. NO MANUFACTURING VARIANCE OBSERVED RELATED TO THIS EVENT IN THE DEVICE HISTORY RECORD REVIEW.

    Description of Event or Problem · 1

    AFTER IMPLANT WHILE CHECKING DRAWBACK, AIR WAS COMING WITH BLOOD. REMOVED AND ANOTHER IMPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VORTEX-AC WITH KIT VASCULAR ACCESS PORT LJT ANGIODYNAMICS, INC. NA 29215

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other