BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNKNOWN GASTROSTOMY FEEDING TUBE

    MDR report key: 24002435 · Received January 8, 2026

    Report

    Report Number
    9611594-2026-00006
    Event Type
    Malfunction
    Date Received
    January 8, 2026
    Date of Event
    December 2, 2025
    Report Date
    January 7, 2026
    Manufacturer
    AVANOS MEDICAL INC.
    Product Code
    KNT
    PMA / PMN Number
    UNKNOWN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    A REVIEW OF THE DEVICE HISTORY RECORD IS NOT POSSIBLE AS NO LOT NUMBER WAS PROVIDED; THEREFORE, THE UDI-PI IS UNAVAILABLE. THE SAMPLE IS REPORTED TO BE AVAILABLE BUT HAS NOT YET BEEN RECEIVED BY THE MANUFACTURER. ALL INFORMATION REASONABLY KNOWN AS OF 07 JAN 2026 HAS BEEN INCLUDED IN THIS HEALTH AUTHORITY REPORT. SHOULD ADDITIONAL INFORMATION BE OBTAINED, A FOLLOW-UP HEALTH AUTHORITY REPORT WILL BE PROVIDED. THE INFORMATION PROVIDED BY AVANOS MEDICAL INC. REPRESENTS ALL OF THE KNOWN INFORMATION AT THIS TIME. DESPITE GOOD FAITH EFFORTS TO OBTAIN ADDITIONAL INFORMATION, THE COMPLAINANT/REPORTER WAS UNABLE OR UNWILLING TO PROVIDE ANY FURTHER PATIENT, PRODUCT, OR PROCEDURAL DETAILS TO AVANOS MEDICAL INC. AVANOS MEDICAL INC. HAS NO INDEPENDENT KNOWLEDGE OF THE REPORTED EVENT BUT IS RELAYING THE INFORMATION PROVIDED BY THE USER FACILITY WHERE THE INCIDENT OCCURRED. THIS PRODUCT INCIDENT IS DOCUMENTED IN THE AVANOS MEDICAL COMPLAINT DATABASE AND IDENTIFIED AS COMPLAINT (B)(4). THIS INFORMATION IS SUBMITTED PURSUANT TO 21CFR803, IN COMPLIANCE WITH THE MEDICAL DEVICE REPORTING REQUIREMENT AND SHOULD NOT BE CONSIDERED TO BE AN ADMISSION THAT AN AVANOS MEDICAL INC. PRODUCT IS DEFECTIVE OR CAUSED SERIOUS INJURY.

    Description of Event or Problem · 0

    IT WAS REPORTED, ¿SHAFT OF TUBE HAS SNAPPED AND TOP DETACHED, BALLOON DEFLATED, SHAFT AND DEFLATED BALLOON FELL INTO STOMACH SAC. PATIENT IS HIGHLY MOBILE. TUBE WAS ONLY INSERTED 10 DAYS PRIOR TO INCIDENT¿. THERE WAS NO HARM TO THE PATIENT. PER ADDITIONAL INFORMATION RECEIVED ON DECEMBER 16, 2025, ¿PATIENT HAD TO PRESENT TO EMERGENCY DEPARTMENT AND OVER COURSE OF 36 HOURS NEEDED X 2 HOSPITAL PRESENTATIONS, X 2 X-RAYS AND X 1 ENDOSCOPIC PROCEDURE WITH ANAESTHETIC TO ATTEMPT RETRIEVAL OF REMAINING TUBE. ALL UNSUCCESSFUL, TUBE PASSED BY NATURAL MEANS LATE ON (B)(6) 2025¿.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    63782 UNKNOWN GASTROSTOMY FEEDING TUBE DH EF BALLOON TUBES PRODUCTS KNT AVANOS MEDICAL INC. UNKNOWN UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 30 YR Female