BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GISH SINGLE POLYMER VASPORT

    MDR report key: 272548 · Received April 3, 2000

    Report

    Report Number
    2021836-2000-00001
    Event Type
    Injury
    Date Received
    April 3, 2000
    Date of Event
    February 4, 2000
    Report Date
    March 3, 2000
    Manufacturer
    GISH BIOMEDICAL, INC.
    Product Code
    DQO
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    DURING THE REMOVAL OF THE DEVICE, A SMALL PORTION OF THE CATHETER TIP BROKE OFF. IT WAS LOCATED IN THE PATIENT'S RIGHT ATRIUM, AND WAS REMOVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GISH SINGLE POLYMER VASPORT CATHETER DQO GISH BIOMEDICAL, INC. SINGLE SEPTUM VASPORT 134912

    Patients

    Seq Age Sex Outcome Treatment
    1 * Required Intervention