BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MIC JEJUNOSTOMY TUBE

    MDR report key: 25280864 · Received May 26, 2026

    Report

    Report Number
    9611594-2026-00362
    Event Type
    Injury
    Date Received
    May 26, 2026
    Date of Event
    February 19, 2025
    Report Date
    May 26, 2026
    Manufacturer
    AVANOS MEDICAL INC.
    Product Code
    KNT
    UDI-DI
    00350770956770
    PMA / PMN Number
    K844745
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE ACTUAL COMPLAINT PRODUCT WAS NOT RETURNED FOR EVALUATION. A REVIEW OF THE DEVICE HISTORY RECORD AND UDI ARE IN-PROGRESS. ALL INFORMATION REASONABLY KNOWN AS OF 26 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 COMPLAINT (B)(4). THIS INFORMATION IS SUBMITTED PURSUANT TO 21 CFR 803, 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

    AVANOS MEDICAL INC. RECEIVED A SINGLE REPORT THAT REFERENCED TWO DIFFERENT INCIDENTS, WHICH WERE ASSOCIATED WITH SEPARATE UNITS, INVOLVING TWO DIFFERENT PATIENTS. THIS IS THE FIRST OF TWO REPORTS. REFER TO 9611594-2026-00362 FOR THE FIRST REPORT. REFER TO 9611594-2026-00363 FOR THE SECOND REPORT. THE CUSTOMER REPORTED THAT THE PATIENT EXPERIENCED ONGOING COMPLICATIONS ASSOCIATED WITH AN AVANOS JEJUNOSTOMY FEEDING TUBE. FOLLOWING INITIAL JEJUNOSTOMY PLACEMENT ON (B)(6) 2025, THE PATIENT REPORTEDLY EXPERIENCED PERSISTENT REDNESS, PURULENT DISCHARGE, RECURRENT CONFIRMED INFECTIONS INCLUDING STAPHYLOCOCCUS, PAIN, BLEEDING, SKIN IRRITATION, TUBE COMPROMISE, FRAGILITY, AND "VOLCANO-LIKE" PROTRUSION AROUND THE STOMA SITE THROUGHOUT 2025 AND CONTINUING INTO 2026. THE TUBE WAS REPORTEDLY EXCHANGED FOR AN AMT G-TUBE IN (B)(6) 2025, AND THE JEJUNOSTOMY TUBE WAS RE-SITED ON (B)(6) 2026. MULTIPLE COURSES OF ANTIBIOTIC THERAPY AND SURGICAL FOLLOW-UP WERE REPORTEDLY REQUIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    26752 MIC JEJUNOSTOMY TUBE DH EF JEJUNOSTOMY PRODUCTS KNT AVANOS MEDICAL INC. 0301-14 30318444 00350770956770

    Patients

    Seq Age Sex Outcome Treatment
    1