BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENVIZION MEDICAL ENVUE ENVIZION MEDICAL ENTERAL FEEDING TUBE

    MDR report key: 12749131 · Received November 3, 2021

    Report

    Report Number
    3008044552-2021-00002
    Event Type
    Injury
    Date Received
    November 3, 2021
    Date of Event
    October 5, 2021
    Report Date
    November 3, 2021
    Manufacturer
    ENVIZION MEDICAL LTD.
    Product Code
    KNT
    PMA / PMN Number
    K2031133
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS NOT RETURNED AND THEREFORE, WAS NOT ABLE TO BE EVALUATED. WITHOUT THE KNOWN SERIAL NUMBER, THE DHR WAS NOT ABLE TO BE REVIEWED. IF ADDITIONAL INFORMATION IS OBTAINED THAT ADDS VALUE TO THE RELEVANT CONTENT OF THIS REPORT AND/OR A CONCLUSION CAN BE DRAWN, A FOLLOW-UP REPORT WILL BE SENT.

    Description of Event or Problem · 1

    DURING INITIAL ATTEMPT AT USE OF THE ENVUE, WHEN INSERTING THE TUBE, NO PATH WAS DISPLAYED ON THE SYSTEM MONITOR. THE TUBE WAS REMOVED AND REPLACED. THE SAME ISSUE OCCURRED WITH THE SECOND TUBE; NO DISPLAY OF TUBE PATH. THE NURSE THEN PROCEEDED TO PLACE THE TUBE WITHOUT THE ASSISTANCE OF THE SYSTEM. THE TUBE WAS PLACED IN THE LUNG AND CAUSED A PNEUMOTHORAX. NO FURTHER INFORMATION AVAILABLE AT THIS TIME

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1647640 ENVIZION MEDICAL ENVUE ENVIZION MEDICAL ENTERAL FEEDING TUBE TUBES, GASTROINTESTINAL (AND ACCESSORIES) KNT ENVIZION MEDICAL LTD. ENV-20000 NI

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Other| R