BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENVUE ENTERAL FEEDING TUBE WITH STYLET AND ENFIT CONNECTOR

    MDR report key: 19369600 · Received May 22, 2024

    Report

    Report Number
    19369600
    Event Type
    Malfunction
    Date Received
    May 22, 2024
    Date of Event
    April 20, 2024
    Report Date
    May 2, 2024
    Manufacturer
    ENVIZION MEDICAL LTD
    Product Code
    KNT
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    VA
    Reporter Occupation
    RISK MANAGER
    Health Professional
    N

    Narratives

    Description of Event or Problem · 0

    PATIENT WITH ENV (ENVUE) ND (NASO-DUODENAL) FEEDING TUBE. FEEDING PUMP ALARMED OCCLUSION. ENV FEEDING TUBE FOUND TO BE CRACKED AT PURPLE CONNECTION PORT. NDT REMOVED, NGT (NASO-GASTIC TUBE) PLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1452672 ENVUE ENTERAL FEEDING TUBE WITH STYLET AND ENFIT CONNECTOR TUBES, GASTROINTESTINAL (AND ACCESSORIES) KNT ENVIZION MEDICAL LTD ENV-08091

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other