BEUDAMED
    FDA Adverse Event Other Summary report: N

    TRIUMPH-VTX

    MDR report key: 1215639 · Received October 20, 2008

    Report

    Report Number
    1056436-2006-00084
    Event Type
    Other
    Date Received
    October 20, 2008
    Date of Event
    November 30, 2006
    Report Date
    October 15, 2008
    Manufacturer
    ANGIODYNAMICS, INC.
    Product Code
    LJT
    Report Source
    Manufacturer report
    Reporter Location
    ME, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    THE CAUSE OF THE HOLE AND CLAMP MARKS ON THE ANTI-KINK SLEEVE NEAR THE DEVICE TITANIUM LOCKING SLEEVE MAY HAVE BEEN INTRODUCED BY A SURGICAL INSTRUMENT CONSISTENT WITH A FORCEP OR HEMOSTAT. A REVIEW OF THE DEVICE HISTORY RECORD SHOWED NO MANUFACTURING VARIANCES RELATED TO THIS EVENT. CAUSE OF THIS EVENT MAY HAVE BEEN USER ERROR.

    Description of Event or Problem · 1

    HOLE IN SILICONE CATHETER, RIGHT WHERE IT CONNECTS TO PORT. THEY ASSUME THAT IT WAS NOT SEALED PROPERLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TRIUMPH-VTX VASCULAR ACCESS PORT LJT ANGIODYNAMICS, INC. NA 28057

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other