BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DUAL PORT INFUSE-A-KIT SYSTEM

    MDR report key: 474012 · Received July 24, 2003

    Report

    Report Number
    1056436-2003-00072
    Event Type
    Malfunction
    Date Received
    July 24, 2003
    Date of Event
    June 25, 2003
    Report Date
    July 24, 2003
    Manufacturer
    HORIZON MEDICAL PRODUCTS, INC.
    Product Code
    LJT
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    LEAKING FROM LATERAL PORT WAS OBSERVED WHEN THE DUAL PORT WAS FLUSHED WITH SALINE. PORT WAS REMOVED AND THE RINGS ON TOP OF THE PORT HAD SEPARATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DUAL PORT INFUSE-A-KIT SYSTEM VASCULAR ACCESS PORT LJT HORIZON MEDICAL PRODUCTS, INC. NA 15870

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Other