BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNKNOWN NASOGASTRIC/NASOINTESTINAL FEEDING TUBES

    MDR report key: 24954981 · Received April 22, 2026

    Report

    Report Number
    9611594-2026-00249
    Event Type
    Malfunction
    Date Received
    April 22, 2026
    Date of Event
    July 24, 2024
    Report Date
    April 21, 2026
    Manufacturer
    AVANOS MEDICAL INC.
    Product Code
    KNT
    PMA / PMN Number
    UNKNOWN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THIS EVENT WAS INITIALLY DEEMED NOT REPORTABLE BASED ON OUR REPORTING STRATEGY ACTIVE AT THE TIME OF THE ALERT DATE; HOWEVER, FOLLOWING A RECENT RETROSPECTIVE REVIEW OF COMPLAINTS THIS EVENT WAS MADE REPORTABLE OUT OF AN ABUNDANCE OF CAUTION. A REVIEW OF THE DEVICE HISTORY RECORD IS NOT POSSIBLE AS NO LOT NUMBER WAS PROVIDED; THEREFORE, THE UDI-PI IS UNAVAILABLE. THE ACTUAL COMPLAINT PRODUCT WAS NOT RETURNED FOR EVALUATION. THE ROOT CAUSE COULD NOT BE DETERMINED. ALL INFORMATION REASONABLY KNOWN AS OF 21 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 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 PATIENTS. THIS IS THE SECOND OF TWO REPORTS. REFER TO 9611594-2026-00248 FOR THE FIRST REPORT. IT WAS REPORTED, "DURING ROUTINE RETAPING OF TRANSPYLORIC (TP) TUBES, RN NOTED A TEAR IN TP TUBING AND LEAKING MILK PRIOR TO REACHING PATIENT. TP TUBE REMOVED AND REPLACED." NO INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    271393 UNKNOWN NASOGASTRIC/NASOINTESTINAL FEEDING TUBES DH CPK NG TUBES KNT AVANOS MEDICAL INC. UNKNOWN UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown