BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LIVER ACCESS & BIOPSY NEEDLE SET

    MDR report key: 17374203 · Received July 20, 2023

    Report

    Report Number
    MW5119816
    Event Type
    Injury
    Date Received
    July 20, 2023
    Date of Event
    June 8, 2023
    Report Date
    July 14, 2023
    Manufacturer
    COOK INCORPORATED
    Product Code
    DYB
    Report Source
    Voluntary report
    Reporter Location
    TX, US
    Reporter Occupation
    003
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    A TRANSJUGULAR BIOPSY WAS BEING PERFORMED WHEN AN INTERNAL CATHETER SEPARATED AND WAS NOTED TO BE INTRAVASCULAR. A SNARE WAS USED AND THE MATERIAL WAS REMOVED WITHOUT HARM TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    597677 LIVER ACCESS & BIOPSY NEEDLE SET INTRODUCER, CATHETER DYB COOK INCORPORATED LABS-100-J-01 15431039

    Patients

    Seq Age Sex Outcome Treatment
    1 Female Required Intervention