BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BETAPORT ACCESS SYSTEM

    MDR report key: 128263 · Received October 22, 1997

    Report

    Report Number
    128263
    Event Type
    Injury
    Date Received
    October 22, 1997
    Date of Event
    September 23, 1997
    Report Date
    September 25, 1997
    Manufacturer
    NORFOLK MEDICAL PRODUCTS, INC.
    Product Code
    LJT
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CA, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    WHILE PERFORMING UPPER GI ON 9/23/97, IT WAS NOTED THAT THE CATHETER HAD BROKEN OFF FROM BETAPORT AND LODGED IN THE HEART. CATHETER WAS REMOVED BY CARDIAC CATHETERIZATION THROUGH FEMORAL VEIN. CATHETER DOME REMOVED ON 9/25/97.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BETAPORT ACCESS SYSTEM Implant 7FR BETA PORT LJT NORFOLK MEDICAL PRODUCTS, INC. * *

    Patients

    Seq Age Sex Outcome Treatment
    1 2.5 YR Hospitalization| R