BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENVIZION MEDICAL ENVUE ENVIZION MEDICAL ENTERAL FEEDING TUBE

    MDR report key: 12457276 · Received September 10, 2021

    Report

    Report Number
    3008044552-2021-00001
    Event Type
    Malfunction
    Date Received
    September 10, 2021
    Date of Event
    May 25, 2021
    Report Date
    September 10, 2021
    Manufacturer
    ENVIZION MEDICAL LTD.
    Product Code
    KNT
    PMA / PMN Number
    K203133
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE WAS NOT RETURNED AND THEREFORE, WAS NOT ABLE TO BE EVALUATED. HOWEVER, A PLAYBACK RECORDING OF THE PLACEMENT WAS PROVIDED AND REVIEWED. A REPRESENTATIVE SYSTEM WAS USED TO SIMULATE THE EVENT AND INVESTIGATE THE POSSIBLE CAUSES. THE INVESTIGATION DEMONSTRATED THAT THE EVENT COULD POSSIBLY BE ATTRIBUTED TO THE REFERENCE SENSOR MOVING FROM THE ORIGINAL POSITION, AFTER THE FIRST INSERTION ATTEMPT, AND IS MOST LIKELY THE CAUSE OF USE ERROR. THE USER MANUAL INSTRUCTS THE USER TO SECURELY ATTACH THE REFERENCE SENSOR TO THE TO THE PATIENT, WHICH DID NOT APPEAR TO BE FOLLOWED. 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 · 0

    IT WAS REPORTED THAT DURING A PROCEDURE THE TUBE ENTERED THE RIGHT PULMONARY AIRWAY. THE TUBE WAS REPOSITION AND A SECOND ATTEMPT TO INSERT TUBE WAS MADE BUT IT REMAINED, AND CONFIRMED BY X-RAY, IN THE RIGHT PULMONARY AIRWAY. THERE WERE NO REPORTED PATIENT IMPACTS AND NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1354882 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