BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LIFEPORT VASCULAR ACCESS SYSTEM

    MDR report key: 514143 · Received March 4, 2004

    Report

    Report Number
    1056436-2004-00007
    Event Type
    Injury
    Date Received
    March 4, 2004
    Date of Event
    January 20, 2004
    Report Date
    March 4, 2004
    Manufacturer
    HORIZON MEDICAL PRODUCTS, INC.
    Product Code
    LJT
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    A DYE STUDY WAS PERFORMED ON THE PORT DUE TO LEAKAGE IN 2004. THE DYE STUDY CONFIRMED LEAKAGE PRESENT NEAR THE PORT AND CATHETER CONNECTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LIFEPORT VASCULAR ACCESS SYSTEM VASCULAR ACCESS PORT LJT HORIZON MEDICAL PRODUCTS, INC. LPS7523 18975

    Patients

    Seq Age Sex Outcome Treatment
    1 36 YR