BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DVILL¿

    MDR report key: 16673138 · Received April 4, 2023

    Report

    Report Number
    16673138
    Event Type
    Malfunction
    Date Received
    April 4, 2023
    Date of Event
    April 13, 2021
    Report Date
    August 2, 2021
    Manufacturer
    B BRAUN INTERVENTIONAL SYSTEMS, INC
    Product Code
    DYB
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    PA
    Reporter Occupation
    RISK MANAGER
    Health Professional
    N

    Narratives

    Description of Event or Problem · 0

    D'VILL INTRODUCER BEING UTILIZED FOR NOBLE STITCH PFO CLOSURE. MD NOTICED UPON WITHDRAWAL OF BLOOD THROUGH SIDE PORT AND STOP COCK THERE WAS A LOT OF AIR IN SYRINGE CONTINUOUSLY. WITH SHEATH ALONE, NO WIRE OR DEVICE INSERTED, AIR ASPIRATION STILL OCCURRED. CONTINUOUS ASPIRATION NEEDED TO ASSURE NO AIR EMBOLUS. PROCEDURE COMPLETED WITH NO HARM TO PATIENT. REMAINING PRODUCT REMOVED FROM STOCK AND SEQUESTERED. COMPANY NOTIFIED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    385919 DVILL¿ INTRODUCER, CATHETER DYB B BRAUN INTERVENTIONAL SYSTEMS, INC 612847

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown