BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VORTEX-LP-AC

    MDR report key: 473121 · Received July 18, 2003

    Report

    Report Number
    1056436-2003-00070
    Event Type
    Malfunction
    Date Received
    July 18, 2003
    Date of Event
    June 24, 2003
    Report Date
    July 18, 2003
    Manufacturer
    HORIZON MEDICAL PRODUCTS, INC.
    Product Code
    LJT
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IN 2003, THE USER FACILITY'S OR SUPPLY COORDINATOR INFORMED THE MANUFACTURER'S SALES REPRESENTATIVE OF THE FOLLOWING: DEVICE IMPLANTED IN 2003 AND REMOVED IN 2003 DUE TO PARTIAL OCCLUSION. ABLE TO INFUSE, BUT NOT ASPIRATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VORTEX-LP-AC VASCULAR ACCESS PORT LJT HORIZON MEDICAL PRODUCTS, INC. NA 15550

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other