BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CORTRAK 2 NG/NI FEED TUBE, ELECTRO-TRANSMITTING STYLET, ENFIT

    MDR report key: 24199509 · Received January 28, 2026

    Report

    Report Number
    9611594-2026-00022
    Event Type
    Malfunction
    Date Received
    January 28, 2026
    Date of Event
    December 1, 2025
    Report Date
    May 27, 2026
    Manufacturer
    AVANOS MEDICAL INC.
    Product Code
    KNT
    UDI-DI
    10350770460984
    PMA / PMN Number
    K220588
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE ACTUAL COMPLAINT PRODUCT WAS RETURNED FOR EVALUATION. A REVIEW OF THE DEVICE HISTORY RECORD AND UDI NUMBER ARE IN-PROGRESS. ALL INFORMATION REASONABLY KNOWN AS OF 27-JAN-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.

    Description of Event or Problem · 0

    IT WAS REPORTED THE "PATIENT ATTENDED THE GASTROENTEROLOGY DAY UNIT TODAY FOR [NASOJEJUNAL] NJ REPLACEMENT. PATIENT'S NJT HAD BEEN BLOCKED/KINKED 2 WEEKS AGO, NOW FELT TO BE IN [THE PATIENT'S] STOMACH. [ANTERIOR X-RAY] AXR DEMONSTRATED THAT THE TUBE WAS IN [THE PATIENT'S] STOMACH. ON REMOVAL OF THE TUBE (10FR CORFLO NJ), ONLY HALF THE TUBE CAME OUT (60CMS) MEANING THERE IS 80CMS OF TUBE LEFT IN [THE PATIENT'S] STOMACH. IT LOOKS LIKE THE TUBE HAS BALLOONED AND SPLIT, AS IF THERE HAS BEEN ATTEMPTS MADE TO UNBLOCK THE TUBE" AND THE PATIENT REPORTS DID NOT ATTEMPT TO UNBLOCK THE TUBE. "NEW NJ PLACED BY [INTERVENTIONAL RADIOLOGY] IR. ARRANGED REPEAT AXR FOR 3-DAYS TO ENSURE TUBE HAS PASSED. BOWEL OBSTRUCTION ADVICE / SAFETY NET ADVICE GIVEN." THERE WAS NO REPORTED INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    40516 CORTRAK 2 NG/NI FEED TUBE, ELECTRO-TRANSMITTING STYLET, ENFIT DH CORTRAK DISPOSABLES KNT AVANOS MEDICAL INC. 42-9551TRAK2 20131775 10350770460984

    Patients

    Seq Age Sex Outcome Treatment
    1