BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VITAL PORT CATHETER

    MDR report key: 11850 · Received January 12, 1994

    Report

    Report Number
    11850
    Event Type
    Injury
    Date Received
    January 12, 1994
    Date of Event
    January 5, 1994
    Report Date
    January 11, 1994
    Manufacturer
    COOK PACEMAKER CORP.
    Product Code
    DQO
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    TX, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    AFTER COMPLETION OF A SCHEDULED REMOVAL OF PORT FROM PT'S LEFT SUBCLAVIAN, IT WAS NOTED THAT A 2 INCH PIECE OF THE INDUCER FROM THE CATHETER WAS NOT ATTACHED. X-RAY CONFIRMED THAT A PIECE OF THE INDUCER WAS IN THE PT'S RIGHT ATRIUM. PT WAS TRANSFERRED TO ANOTHER MEDICAL FACILITY FOR REMOVAL OF PIECE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VITAL PORT CATHETER Implant VITAL PORT VASCULAR ACCESS SYSTEM DQO COOK PACEMAKER CORP.

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Hospitalization| R