BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VITAL PORT

    MDR report key: 19685 · Received February 13, 1995

    Report

    Report Number
    19685
    Event Type
    Injury
    Date Received
    February 13, 1995
    Date of Event
    December 14, 1994
    Report Date
    December 20, 1994
    Manufacturer
    COOK PACEMAKER CORP.
    Product Code
    LTH
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    TN, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    THE TIP OF THE VENA PORT CATH BROKE OFF FROM THE REST OF THE CATHETER AND LODGED IN THE RIGHT VENTRIDE. THE BROKEN PIECE OF CATHETER WAS REMOVED BY A RADIOLOGIST AND THE PORT WAS REMOVED IN SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VITAL PORT Implant VASCULAR ACCESS SYSTEM LTH COOK PACEMAKER CORP. 9012 N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Hospitalization| R