BEUDAMED
    FDA Adverse Event Summary report: N

    MEDIPORT CATHETER

    MDR report key: 24177 · Received August 8, 1995

    Report

    Report Number
    MW1006647
    Date Received
    August 8, 1995
    Date of Event
    July 14, 1995
    Report Date
    July 21, 1995
    Manufacturer
    BARD ACCESS SYSTEMS, INC.
    Product Code
    LJT
    Report Source
    Voluntary report
    Reporter Location
    CA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    THE PRODUCT WAS OWNED, MFG AND DISTRIBUTED BY ORTHO DIAGNOSTICS, INC. MERIDIAN DIAGNOSTICS, INC. PURCHASED THE MFG AND DISTRIBUTION RIGHTS AFTER THE ALLEGED MALFUNCTION OCCURRED. TO DATE, IN-HOUSE EVALUATIONS HAVE IDENTIFIED NO PROBLEMS ASSOCIATED WITH PRODUCT MFG BY MERIDIAN DIAGNOSTICS, INC. WE ARE CURRENTLY OBTAINING DATA FROM EXTERNAL CLINICAL STUDIES. WHEN THESE RESULTS ARE IN, A FINAL FOLLOW-UP MEDWATCH REPORT WILL BE SUBMITTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MEDIPORT CATHETER Implant LJT BARD ACCESS SYSTEMS, INC. 36JD6111

    Patients

    Seq Age Sex Outcome Treatment
    1 38 YR