BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MIC GASTRIC-JEJUNAL FEEDING TUBE KIT WITH ENFIT CONNECTOR

    MDR report key: 24975121 · Received April 23, 2026

    Report

    Report Number
    9611594-2026-00196
    Event Type
    Malfunction
    Date Received
    April 23, 2026
    Date of Event
    March 2, 2026
    Report Date
    May 22, 2026
    Manufacturer
    AVANOS MEDICAL INC.
    Product Code
    KNT
    UDI-DI
    00350770445779
    PMA / PMN Number
    K921370
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE SAMPLE IS REPORTED TO BE AVAILABLE BUT HAS NOT YET BEEN RECEIVED BY THE MANUFACTURER. A REVIEW OF THE DEVICE HISTORY RECORD AND UDI ARE IN-PROGRESS. THE ROOT CAUSE HAS NOT BEEN ESTABLISHED. ALL INFORMATION REASONABLY KNOWN AS OF 23 APR 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.

    Additional Manufacturer Narrative · 0

    THE PRODUCT INVOLVED IN THE REPORT HAS BEEN RETURNED AND THE INVESTIGATION REMAINS IN PROGRESS AT THIS TIME. ALL INFORMATION REASONABLY KNOWN AS OF 22 MAY 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 (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 THAT AN 83-YEAR-OLD PATIENT WHO HAS HAD A GASTROJEJUNOSTOMY TUBE IN PLACE SINCE (B)(6) 2025, FOR ENTERAL NUTRITION AND DUODOPA ADMINISTRATION. ON (B)(6) 2026, HE NOTICED AT HOME THAT THE TUBE HAD ACCIDENTALLY SLIPPED OUT. THE TUBE WAS SUCCESSFULLY REINSERTED INTO THE STOMACH AT HOME. THE PATIENT WAS RECALLED FOR AN EMERGENCY CONSULTATION TO HAVE A SIMPLE GASTROSTOMY TUBE WITH A BALLOON INFLATED TO 10 CC OF WATER PLACED IN ORDER TO RESUME TREATMENT. A SURGICAL INTERVENTION IS SCHEDULED LATER TO REPOSITION A GASTROJEJUNAL TUBE. IF, IN THE MEANTIME, THE PATIENT FINDS THAT THE EFFECTIVENESS IS JUST AS GOOD WITH THE GASTRIC TUBE, THE APPOINTMENT WILL BE CANCELLED, AND THE DEVICE COULD BE CHANGED EVERY 6 MONTHS DURING A ROUTINE CONSULTATION. ON (B)(6) 2026 IT WAS CONFIRMED TO RELATE TO A NEW STOMA SITE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    357623 MIC GASTRIC-JEJUNAL FEEDING TUBE KIT WITH ENFIT CONNECTOR DH EF BALLOON TUBES PRODUCTS KNT AVANOS MEDICAL INC. 8650-18 30369989 00350770445779

    Patients

    Seq Age Sex Outcome Treatment
    1