BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CVI VITAL-PORT

    MDR report key: 278479 · Received May 16, 2000

    Report

    Report Number
    MW1018918
    Event Type
    Malfunction
    Date Received
    May 16, 2000
    Date of Event
    January 18, 2000
    Report Date
    May 16, 2000
    Manufacturer
    COOK VASCULAR INC.
    Product Code
    LJT
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    GA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    FRACTURED-OFF CATHETER SEGMENT MEASURING 8.8 MM LONG. THE FRACTURE WAS LOCATED AT THE TIP OF THE CATHETER LOCK AND EXHIBITED A SLIGHTLY ELLIPTICIZED CROSS SECTION. THE FRACTURE SURFACE WAS SOMEWHAT ROUGH TOWARD THE BOTTOM OF THE PORT, ASSUMING THAT THE CATHETER LOCK AND CATHETER HAD NOT BEEN ROTATED DURING OR SUBSEQUENT TO EXPLANT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CVI VITAL-PORT IMPLANTABLE PORT LJT COOK VASCULAR INC. 5016-MP *

    Patients

    Seq Age Sex Outcome Treatment
    1 10 MO