BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROTEKDUO CANNULA

    MDR report key: 8260166 · Received January 18, 2019

    Report

    Report Number
    8260166
    Event Type
    Malfunction
    Date Received
    January 18, 2019
    Date of Event
    December 18, 2018
    Report Date
    December 20, 2018
    Manufacturer
    CARDIAC ASSIST, INC.
    Product Code
    DWF
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    WI
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PROTEK DUO CANNULA FOUND TO HAVE A SMALL CRACK CAUSING BUBBLES. DISCOVERED BY SURGEON IN THE OPERATING ROOM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    53265 PROTEKDUO CANNULA CATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPULMONARY BYPASS DWF CARDIAC ASSIST, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 13505 DA Other