BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CORTRAK 2 NG/NI FEEDING TUBE, ELECTRO STYLET, ENFIT CONNECTOR

    MDR report key: 23625002 · Received November 21, 2025

    Report

    Report Number
    9611594-2025-00297
    Event Type
    Injury
    Date Received
    November 21, 2025
    Date of Event
    October 23, 2025
    Report Date
    May 21, 2026
    Manufacturer
    AVANOS MEDICAL INC.
    Product Code
    KNT
    UDI-DI
    10350770460984
    PMA / PMN Number
    K220588
    Adverse Event
    Yes
    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 21-NOV-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 THAT DURING PLACEMENT OF A NASOJEJUNAL (NJ) TUBE, THE GUIDEWIRE PERFORATED THE TUBE AND CAUSED TRAUMA TO THE ESOPHAGUS OF THE PATIENT. ADDITIONAL INFORMATION RECEIVED 03-NOV-2025. STATED WHILE THE CLINICIAN WAS INSERTING THE NJ TUBE ON AN INTENSIVE CARE UNIT (ICU) PATIENT, "LARGE FUNDAL COIL NOTED ON SCREEN, SLOWLY PULLED WIRE AND TUBE BACK UNTIL COIL REMOVED. ON RE-INSERTING WIRE INTO TUBE, THE WIRE MOVED UNUSUALLY AND VERY SUDDENLY FORWARD. [THE CLINICIAN] INSTANTLY REMOVED THE TUBE FROM THE PATIENT AND FOUND 10+CM OF ELECTROMAGNETIC WIRE HAS PERFORATED THE TUBE. THE TUBE WAS LIKELY PERFORATED WHILST IN THE PATIENT'S ESOPHAGUS (35CM) .[THE CLINICIAN] STOPPED THE PROCEDURE AND SPOKE WITH THE ICU CONSULTANT IMMEDIATELY.PATIENT HAD LOCALIZED BLEEDING, THE NG WAS ASPIRATED, AND IT WAS BLOOD STAINED/BLOOD CONTAINING."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    161547 CORTRAK 2 NG/NI FEEDING TUBE, ELECTRO STYLET, ENFIT CONNECTOR DH CORTRAK DISPOSABLES KNT AVANOS MEDICAL INC. 42-9551TRAK2 20131775 10350770460984

    Patients

    Seq Age Sex Outcome Treatment
    1