BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENVUE FEEDING TUBE PLACEMENT SYSTEM

    MDR report key: 17450991 · Received August 3, 2023

    Report

    Report Number
    3011548489-2023-00002
    Event Type
    Injury
    Date Received
    August 3, 2023
    Date of Event
    May 22, 2023
    Report Date
    September 6, 2023
    Manufacturer
    ENVIZION MEDICAL, LTD.
    Product Code
    KNT
    UDI-DI
    B483EVN200000
    PMA / PMN Number
    K203133
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ON THURSDAY, 06.15.2023, WE RECEIVED THE PLACEMENT FILES AND CONDUCTED AN ANALYSIS. IN BOTH CASES THE RED ARROW AND THE DEVIATION! MESSAGE APPEARED ON THE SCREEN INDICATING THAT THE FEEDING TUBE WAS DEVIATING TOWARDS THE LUNGS. HOWEVER, THE USERS CONTINUED TO ADVANCE THE FEEDING TUBE. ADDITIONAL INFORMATION WAS RECEIVED ON 7/12/2023 FROM THE SITE VIA EMAIL INDICATING THAT THEY BELIEVED THE DEVICE WAS A CONTRIBUTING FACTOR TO THE EVENT AND THEREFORE THE COMPLAINT IS BEING RE-OPENED FOR FURTHER INVESTIGATION.

    Description of Event or Problem · 0

    A LUNG PLACEMENT OCCURRED ON (B)(6) 2023. INTERVENTION WAS REQUIRED TO REMOVE THE FEEDING TUBE FROM THE LUNG TO PREVENT INJURY. BASED ON THE INFORMATION PROVIDED NO ACTUAL INJURY OCCURRED TO THE PATIENT.

    Description of Event or Problem · 0

    A LUNG PLACEMENT OCCURRED ON (B)(6) 2023.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1470260 ENVUE FEEDING TUBE PLACEMENT SYSTEM NG FEEDING TUBE KNT ENVIZION MEDICAL, LTD. ENV-20000 N/A B483EVN200000

    Patients

    Seq Age Sex Outcome Treatment
    1 Male Required Intervention