BEUDAMED
    FDA Adverse Event Other Summary report: N

    TRIUMPH-VTX

    MDR report key: 1215641 · Received October 20, 2008

    Report

    Report Number
    1056436-2006-00082
    Event Type
    Other
    Date Received
    October 20, 2008
    Date of Event
    November 6, 2006
    Report Date
    October 15, 2008
    Manufacturer
    ANGIODYNAMICS, INC.
    Product Code
    LJT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPLAINT WAS CONFIRMED FOR "THE ATTACHMENT SYSTEM COMING OFF", IT APPEARS THE STEM BECAME DETACHED DUE TO NO GLUE/ADHESIVE. NO MANUFACTURING VARIANCES RELATED TO THIS EVENT OBSERVED IN THE DEVICE HISTORY RECORD REVIEW. A CORRECTIVE ACTION WAS IMPLEMENTED TO CORRECT THIS ISSUE.

    Description of Event or Problem · 1

    DR. ATTEMPTED TO IMPLANT THIS PORT. THE ATTACHMENT SYSTEM CAME OFF WHILE HE WAS CONNECTING IT TO THE CATHETER. A SECOND PORT WAS OPENED AND USED WITHOUT INCIDENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TRIUMPH-VTX VASCULAR ACCESS PORT LJT ANGIODYNAMICS, INC. NA 25660

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other