BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LIFEPORT VASCULAR ACCESS SYSTEM

    MDR report key: 379178 · Received March 4, 2002

    Report

    Report Number
    1056436-2002-00015
    Event Type
    Injury
    Date Received
    March 4, 2002
    Date of Event
    November 28, 2001
    Report Date
    March 4, 2002
    Manufacturer
    HORIZON MEDICAL PRODUCTS, INC.
    Product Code
    LJT
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    INVALID DATA

    Narratives

    Description of Event or Problem · 1

    IN 01/2002, A MEDWATCH REPORT (UF#, NOT PROVIDED) WAS RECEIVED FROM THE DEPT OF HEALTH AND HUMAN SERVICES (CDRH MW #1023659) THAT STATES THE FOLLOWING: AFTER PLACEMENT OF DOUBLE LUMEN PORT-A-CATH WITHOUT COMPLICATIONS BY INTERVENTIONAL RADIOLOGIST. IV CONTRAST WAS INJECTED THROUGH THE MEDIAL CHAMBER OF THE DEVICE. EXTRAVASATION WAS NOTED APPROX 2CM FROM THE JUNCTION AREA. THERE WAS NO EVIDENCE OF EXTRAVASATION THROUGH THE LATERAL CHAMBER. A NEW CHAMBER WAS INSERTED WITHOUT COMPLICATIONS. PT DID NOT SUSTAIN ANY SIGNIFICANT MORBIDITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LIFEPORT VASCULAR ACCESS SYSTEM VASCULAR ACCESSPORT LJT HORIZON MEDICAL PRODUCTS, INC. NA 15777

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN