BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VORTEX PORT

    MDR report key: 171145 · Received June 4, 1998

    Report

    Report Number
    1450392-1998-00004
    Event Type
    Injury
    Date Received
    June 4, 1998
    Date of Event
    March 23, 1998
    Report Date
    April 30, 1998
    Manufacturer
    NORFOLK MEDICAL PRODUCTS, INC.
    Product Code
    LJT
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    INVALID DATA

    Narratives

    Description of Event or Problem · 1

    ACCORDING TO THE HEALTH CARE PROVIDER, DURING THE PORT EXPLANT PROCEDURE, THE CATHETER BROKE AND PT WAS TRANSFERRED TO THE RADIOLOGY DEPT WHERE THE DISTAL PORTION OF THE CATHETER WAS RETRIEVED. THE DISTAL PORTION OF THE CATHETER PIECE WAS DISCARDED. ONLY THE PORT WITH ATTACHED PIECE OF CATHETER WAS RETURNED TO THE MFR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VORTEX PORT Implant DRUG DELIVERY DEPOT (VASCULAR ACCESS PORT) LJT NORFOLK MEDICAL PRODUCTS, INC. P5455 970901

    Patients

    Seq Age Sex Outcome Treatment
    1 * Required Intervention