BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VORTEX MP

    MDR report key: 2220896 · Received August 12, 2011

    Report

    Report Number
    2220896
    Event Type
    Malfunction
    Date Received
    August 12, 2011
    Date of Event
    July 14, 2011
    Report Date
    July 14, 2011
    Manufacturer
    ANGIODYNAMICS
    Product Code
    LJT
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    AR, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PER RADIOLOGY REPORT: THERE HAS BEEN AN INTERVAL DISCONNECT BETWEEN THE INFUSE-A-PORT HUB AND THE CATHETER WITH A DISTANCE OF APPROXIMATELY 1.5 CM BETWEEN THE TWO. THE CATHETER STILL APPEARS TO BE IN SATISFACTORY POSITION. THE RIGHT-SIDED VP SHUNT CATHETER TUBING IN THE VISUALIZED PORTION IS INTACT AS WELL. NO ACUTE ABNORMALITIES ARE SEEN IN THE CHEST.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VORTEX MP PORT, CATHETER, IMPLANTED LJT ANGIODYNAMICS * *

    Patients

    Seq Age Sex Outcome Treatment
    1 6 YR