BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENVUE FEEDING TUBE PLACEMENT SYSTEM

    MDR report key: 17513394 · Received August 11, 2023

    Report

    Report Number
    3011548489-2023-00003
    Event Type
    Injury
    Date Received
    August 11, 2023
    Date of Event
    July 11, 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

    Description of Event or Problem · 0

    ON (B)(6) 2023 ENVIZION WAS MADE AWARE THAT A LUNG PLACEMENT OCCURRED ON 11JUL2023 AND CAUSED THE PATIENT TO DESAT WITH SPO2 DIVING DOWN AS LOW AS 58%.

    Description of Event or Problem · 0

    ON (B)(6) 2023 ENVIZION WAS MADE AWARE THAT A LUNG PLACEMENT OCCURRED ON (B)(6) 2023 AND CAUSED THE PATIENT TO DESAT WITH SPO2 DIVING DOWN AS LOW AS 58%.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    595288 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