BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENVUE® ENTERAL FEEDING TUBE WITH STYLET AND ENFIT® CONNECTOR

    MDR report key: 22150328 · Received June 5, 2025

    Report

    Report Number
    22150328
    Event Type
    Malfunction
    Date Received
    June 5, 2025
    Date of Event
    April 21, 2025
    Report Date
    May 23, 2025
    Manufacturer
    ENVUE MEDICAL (USA) INC.
    Product Code
    KNT
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    TX
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    PATIENT CURRENTLY HAS DOBBHOFF IN PLACE. ON [REDACTED] PATIENT HAD AN ABD XR [ABDOMINAL XRAY] AND SHOWED FRACTURING OF THE DISTAL TUBING, WITH A SECTION OF MISSING TUBING. THE NEXT DAY [DATE REDACTED] DR [REDACTED] REMOVED DOBBHOFF FROM PATIENT. TIP OF DOBBHOFF MISSING AND MULTIPLE FRACTURING IN TUBING. PATIENT TO HAVE CT ABDOMEN/PELVIS TODAY. DOBBHOFF TUBING TO REMAIN ON 10 BLUE UNTIL FURTHER NOTICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    885874 ENVUE® ENTERAL FEEDING TUBE WITH STYLET AND ENFIT® CONNECTOR TUBES, GASTROINTESTINAL (AND ACCESSORIES) KNT ENVUE MEDICAL (USA) INC. 12EFT140S K24M241

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Male