BEUDAMED
    FDA Adverse Event Other Summary report: N

    MACROPORT INFUSE-A-KIT SYSTEM

    MDR report key: 1215643 · Received October 20, 2008

    Report

    Report Number
    1056436-2006-00081
    Event Type
    Other
    Date Received
    October 20, 2008
    Date of Event
    October 18, 2006
    Report Date
    October 15, 2008
    Manufacturer
    ANGIODYNAMICS, INC.
    Product Code
    LJT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPLAINT, "LEAKED AROUND PROXIMAL END WHEN FLUSHING", WAS CONFIRMED. THE CAUSE OF THE COMPLAINT MAY HAVE BEEN DUE TO THE O-RING BEING OFF SET, CRIMPED AND TORE. NO MANUFACTURING VARIANCES WERE OBSERVED IN THE DEVICE HISTORY RECORD REVIEW RELATED TO THIS EVENT.

    Description of Event or Problem · 1

    LEAK FOUND AROUND THE PROXIMAL PART OF THE CATHETER WHEN FLUSHING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MACROPORT INFUSE-A-KIT SYSTEM VASCULAR ACCESS PORT LJT ANGIODYNAMICS, INC. NA 26258

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other