BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENVUE ENTERAL FEEDING TUBES

    MDR report key: 17450990 · Received August 3, 2023

    Report

    Report Number
    3011548489-2023-00001
    Event Type
    Injury
    Date Received
    August 3, 2023
    Date of Event
    May 18, 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
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ON THURSDAY, 06.15.2023, WE RECEIVED THE PLACEMENT FILES (LOGS) AND CONDUCTED AN ANALYSIS. INITIAL CONCLUSION IS THAT THE DEVICE PERFORMED AS EXPECTED AND DID NOT MALFUNCTION. LUNG PLACEMENTS ARE AN EXPECTED EVENT IN EFT PLACEMENT. ADDITIONAL TESTING OF ACTUAL UNIT PLANNED BASED ON ADDITIONAL INFORMATION FROM THE HOSPITAL RECEIVED 07.12.2023.

    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. INTERVENTION WAS REQUIRED TO REMOVE THE FEEDING TUBE FROM THE LUNG TO PREVENT INJURY. BASED ON THE INFORMATION PROVIDE NO ACTUAL INJURY OCCURRED TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1470259 ENVUE ENTERAL FEEDING TUBES NG FEEDING TUBE KNT ENVIZION MEDICAL, LTD. ENV-20000 N/A B483EVN200000

    Patients

    Seq Age Sex Outcome Treatment
    1 Male Required Intervention