BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNKNOWN NASOGASTRIC TUBE

    MDR report key: 24298203 · Received February 9, 2026

    Report

    Report Number
    9611594-2026-00045
    Event Type
    Malfunction
    Date Received
    February 9, 2026
    Date of Event
    December 23, 2025
    Report Date
    April 23, 2026
    Manufacturer
    AVANOS MEDICAL INC.
    Product Code
    KNT
    PMA / PMN Number
    UNKNOWN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    EI
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE ACTUAL COMPLAINT PRODUCT WAS NOT RETURNED FOR EVALUATION. A REVIEW OF THE DEVICE HISTORY RECORD IS NOT POSSIBLE AS NO LOT NUMBER WAS PROVIDED; THEREFORE, THE UDI-PI IS UNAVAILABLE. A ROOT CAUSE COULD NOT BE DETERMINED. ALL INFORMATION REASONABLY KNOWN AS OF 09 FEB 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 PICTURES PROVIDED CONFIRMS TUBING EXPANDED TO FORM A BALLOON SHAPE WHICH BURST CAUSING A SEPARATION OF THE TUBE. HOWEVER, PROCESS EVALUATION AND TOOLS ARE IN RIGHT CONDITIONS AND THERE WERE NO ACTIVITIES THAT COULD IDENTIFIED THE CAUSE OF THIS TYPE OF DAMAGE IN THIS PARTICULAR DEVICE INCIDENT, THE FAILURE REPORTED MIGHT NOT BE ASSOCIATED TO THE MANUFACTURING PROCESS. IFU CONTAINS RECOMMENDATIONS FOR TUBE MAINTENANCE: ¿IT IS RECOMMENDED THE TUBE BE IRRIGATED EVERY 4 HOURS WITH UP TO 20 ML OF WATER (UP TO 10 ML FOR INFANTS OR CHILDREN) BEFORE AND AFTER MEDICATION ADMINISTRATION OR WHEN FEEDING FORMULA IS INTERRUPTED. WARNING: VIGOROUS SYRINGE FORCE SHOULD NOT BE USED TO IRRIGATE, ADMINISTER LIQUIDS OR UNBLOCK THE TUBE." THEREFORE, THE ROOT CAUSE OF THE REPORTED ISSUE HAS NOT BEEN CONCLUSIVELY DETERMINED. 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 (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, A PATIENT HAD AN AVANOS NG TUBE INSERTED ON (B)(6) 2025 FOR ENTERAL FEEDING PURPOSES. ON THE (B)(6) 2025, AN ABDOMINAL X-RAY WAS TAKEN WHICH INCIDENTALLY SHOWED THAT THE NG TUBE HAD FRACTURED AND A 15CM FRAGMENT OF THE TUBE WAS POSITIONED IN THE RECTUM SIGMOID. THE REMAINING NG TUBE WAS REMOVED (SEE PICTURES ATTACHED). A REPEAT ABDOMINAL X-RAY WAS PERFORMED ON (B)(6) 2025 WHICH SHOWED THE TUBE FRAGMENT WAS STILL IN THE RECTUM SIGMOID. THE PATIENT WAS PRESCRIBED LAXATIVES AND A FURTHER ABDOMINAL X-RAY ON (B)(6) 2026 WAS TAKEN AND THE FRAGMENT WAS NO LONGER VISIBLE AND THEREFORE ASSUMED TO HAVE BEEN PASSED. PER ADDITIONAL INFORMATION RECEIVED ON 23JAN2026, THE PATIENT WAS RECEIVING BOLUS FEEDINGS. NO BLENDED FEEDS WERE USED. THE BOLUS FEEDS WERE IDDSI LEVEL 2 CONSISTENCY FORMULAS (FORTISIP COMPACT PROTEIN/ENSURE COMPACT) DILUTED WITH A SMALL VOLUME OF WATER. THE FEEDING TUBE WAS ALSO USED TO ADMINISTER BOTH LIQUID AND CRUSHED MEDICATIONS. THE TUBE WAS FLUSHED BEFORE AND AFTER EACH BOLUS FEEDING (FOUR TIMES DAILY) AND BEFORE AND AFTER MEDICATION ADMINISTRATION. A 60 ML SYRINGE WAS USED FOR ALL FLUSHING, PERFORMED MANUALLY. THERE WAS NO DOCUMENTED HISTORY OF TUBE CLOGGING PRIOR TO THE REPORTED RUPTURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    356433 UNKNOWN NASOGASTRIC TUBE DH CPK NG TUBES KNT AVANOS MEDICAL INC. UNKNOWN UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Female