BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MIC-KEY GASTRIC-JEJUNAL FEED TUBE KIT EXTENSION SETS-22 FR, 2.0 M

    MDR report key: 23364202 · Received October 22, 2025

    Report

    Report Number
    9611594-2025-00247
    Event Type
    Malfunction
    Date Received
    October 22, 2025
    Report Date
    December 12, 2025
    Manufacturer
    AVANOS MEDICAL INC.
    Product Code
    KNT
    UDI-DI
    00350770441269
    PMA / PMN Number
    K922667
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MS, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE HISTORY RECORD FOR THE REPORTED LOT NUMBER, 30279807, IN THIS COMPLAINT WAS REVIEWED AND THE MATERIAL WAS PRODUCED ACCORDING TO THE MANUFACTURING PROCEDURES AND MET THE QUALITY REQUIREMENTS. ALL INFORMATION REASONABLY KNOWN AS OF 11-DEC-2025 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 EVENT REPORTED BUT IS RELAYING THE INFORMATION THAT WAS PROVIDED BY THE USER FACILITY WHERE THE INCIDENT OCCURRED. THIS PRODUCT INCIDENT IS DOCUMENTED IN THE AVANOS MEDICAL, INC. 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 ACTUAL COMPLAINT PRODUCT WAS NOT RETURNED FOR EVALUATION. A REVIEW OF THE DEVICE HISTORY RECORD AND UDI NUMBER ARE IN-PROGRESS. ALL INFORMATION REASONABLY KNOWN AS OF 22-OCT-2025 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 EVENT REPORTED BUT IS RELAYING THE INFORMATION THAT WAS PROVIDED BY THE USER FACILITY WHERE THE INCIDENT OCCURRED. THIS PRODUCT INCIDENT IS DOCUMENTED IN THE AVANOS MEDICAL, INC. 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 "THE 1.5 WAS TOO TIGHT AND THE 2.0 I SUPPOSE IS TOO BIG BECAUSE IT SPINS." THE PATIENT IS "STILL HAVING GRANULATION TISSUE/BLEEDING ISSUES WITH THIS NEW ONE, NOT AS BAD AS BEFORE BUT STILL THERE NONETHELESS." ADDITIONAL INFORMATION RECEIVED 11-OCT-2025 STATED THE PATIENT'S TUBE "COMPLETELY BROKE ON (B)(6) 2025 WHILE THE PATIENT WAS INPATIENT WITH BACTEREMIA. IT HAD BEEN LEAKING AND GRADUALLY WORSENING EACH DAY. WHEN IT BROKE, A LARGE QUANTITY OF STOMACH ACID BEGAN TO FLOW CONTINUALLY FOR THE NEXT 8-HOURS UNTIL IT COULD BE REPLACED. IT BURNED PATIENT'S SKIN WITH THE CONSTANT ACID EXPOSURE. THE INTERVENTIONAL RADIOLOGY [DEPARTMENT] LOCATED AN AVANOS 1.7 CM STOMA LENGTH GJ LOW PROFILE TUBE. THEY COULD SEE ON THE FLUOROSCOPY SCANS DURING PROCEDURE THAT THE TUBE HAD COILED IN THE STOMACH AND WAS NOT IN THE PROPER LOCATION OF THE SMALL INTESTINES. IT WAS NOTED THE PROVIDER "THINKS THIS MAY HAVE BEEN CAUSED BY THE IMPROPERLY FITTING TUBE (TOO LARGE). IT WAS A TECHNICALLY DIFFICULT PROCEDURE LASTING ABOUT 90-MINUTES." THE SKIN AROUND STOMA WAS QUITE IRRITATED, INFLAMED, ETC. THE PHYSICIAN STATED, "FUTURE REPLACEMENTS WILL NEED TO BE EITHER GENERAL ANESTHESIA AS IT WILL TAKE MORE AGGRESSIVE INSERTION TECHNIQUES WITH MY UNUSUAL ANATOMY AND GASTROPARESIS CAUSING THE TRADITIONAL METHOD OF INSERTION TO NOT WORK WELL." IT WAS REPORTED, PATIENT BELIEVES TUBE SIZE IS TOO SMALL. SHE IS UNABLE TO GET A GAUZE BETWEEN HER ABDOMEN AND THE TUBE AND THERE IS BLEEDING. PLAN TO SEE DOCTOR FOR SIZING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2777252 MIC-KEY GASTRIC-JEJUNAL FEED TUBE KIT EXTENSION SETS-22 FR, 2.0 M DH EF BALLOON TUBES PRODUCTS KNT AVANOS MEDICAL INC. 8270-22-2.0-45 30279807 00350770441269

    Patients

    Seq Age Sex Outcome Treatment
    1 44 YR Female