BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNKNOWN CORTRAK NASOGASTRIC TUBE

    MDR report key: 23938651 · Received December 31, 2025

    Report

    Report Number
    9611594-2025-00343
    Event Type
    Malfunction
    Date Received
    December 31, 2025
    Report Date
    February 27, 2026
    Manufacturer
    AVANOS MEDICAL INC.
    Product Code
    KNT
    PMA / PMN Number
    UNKNOWN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VT, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE SAMPLE DEVICE WAS EVALUATED. THE SAMPLE DID NOT ARRIVE WITH THE ORIGINAL PACKAGING. NO OTHER COMPONENT RECEIVED. THE RETURNED SAMPLE DEVICE WAS EXAMINED AND INFUSED WITH WATER SHOWING THAT THE TUBING HAD SIGNS OF DAMAGES (TEAR/HOLE). THERE WERE EXTERNAL DENT MARKS IDENTIFIED AFTER THE SAMPLE WAS INSPECTED UNDER MAGNIFICATION BELOW THE Y-CONNECTOR. THE AREA WHERE THE UNEVEN SURFACE APPEARED WRINKLED. THE TUBING WAS CUT TO VIEW THE INSIDE SURFACE. ONCE THE TUBING WAS OPENED, UNDER MAGNIFICATION, THERE WAS A TEAR WAS FOUND ON THE INNER WALLS OF THE TUBING. THE INCIDENT REPORTED HAS BEEN CONFIRMED PER THE SAMPLE EVALUATION, THE RETURNED TUBE WAS EXAMINED AND INFUSED WITH WATER SHOWING THAT THE TUBING HAD SIGNS OF DAMAGES (TEAR/HOLE) JUST BELOW THE Y-CONNECTOR. ROOT CAUSE COULD NOT BE DETERMINED. ALL INFORMATION REASONABLY KNOWN AS OF 29-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 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 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. ALL INFORMATION REASONABLY KNOWN AS OF 31-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.

    Description of Event or Problem · 0

    IT WAS REPORTED THE 8FR CORTRAK2 NASOGASTRIC TUBE "WAS PLACED ON THE PATIENT IT APPEARED TO HAVE A PIN HOLE IN THE TUBE WHICH CAUSED IT TO LEAK NUTRITION. CLINICIANS PLACED SOME DERMABOND ON THE HOLE IN ORDER FOR THE TUBE NOT TO LEAK. THE TUBE WAS REPLACED YESTERDAY DUE TO THE PATIENT BEING DISCHARGED AND CLINICIANS DID WANT TO SEND THE PATIENT HOME WITH THE PIN HOLE IN THE TUBE." THERE WAS NO HARM TO THE PATIENT DUE TO THIS EVENT. THERE WAS NO REPORTED INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1917675 UNKNOWN CORTRAK NASOGASTRIC TUBE DH CORTRAK DISPOSABLES KNT AVANOS MEDICAL INC. UNKNOWN UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown