BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VORTEX-LP WITH KIT

    MDR report key: 510066 · Received February 5, 2004

    Report

    Report Number
    1056436-2004-00004
    Event Type
    Injury
    Date Received
    February 5, 2004
    Date of Event
    January 16, 2004
    Report Date
    February 5, 2004
    Manufacturer
    HORIZON MEDICAL PRODUCTS, INC.
    Product Code
    LJT
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    THE PORT WAS MAKING A SLOSHING NOISE. MEDICATIONS CAME BACK OUT OF PORT WITH FLUSHING. UPON REMOVAL OF THE DEVICE, THE PHYSICIAN NOTED THAT THE CATHETER HAD DETACHED FROM THE PORT BOYD. THE PT WAS TRANSFERRED TO ANOTHER FACILITY TO HAVE THE CATHETER PORTION REMOVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VORTEX-LP WITH KIT VASCULAR ACCESS PORT LJT HORIZON MEDICAL PRODUCTS, INC. NA 18451

    Patients

    Seq Age Sex Outcome Treatment
    1 10 YR Required Intervention