BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEPORT VASCULAR ACCESS SYSTEM

    MDR report key: 533881 · Received March 17, 2004

    Report

    Report Number
    1056436-2004-00010
    Event Type
    Malfunction
    Date Received
    March 17, 2004
    Date of Event
    February 25, 2004
    Report Date
    March 17, 2004
    Manufacturer
    HORIZON MEDICAL PRODUCTS, INC.
    Product Code
    LJT
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IN 2004, THE USER FACILITIES MATERIALS MGR OR INFORMED THE MFR'S DISTRIBUTOR OF THE FOLLOWING: BOTH PORT CATHETERS LEAK AT THE HUB WHEN PHYSICIAN TRIED TO PLACE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LIFEPORT VASCULAR ACCESS SYSTEM VASCULAR ACCESSPORT LJT HORIZON MEDICAL PRODUCTS, INC. LPS7523 19397

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN