BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CORTRAK 2 ENTERAL ACCESS SYSTEM

    MDR report key: 23827792 · Received December 17, 2025

    Report

    Report Number
    3011270181-2025-00053
    Event Type
    Injury
    Date Received
    December 17, 2025
    Date of Event
    November 19, 2025
    Report Date
    December 17, 2025
    Manufacturer
    AVANOS MEDICAL INC.
    Product Code
    KNT
    UDI-DI
    00350770007915
    PMA / PMN Number
    K220588
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE ACTUAL COMPLAINT PRODUCT WAS NOT RETURNED FOR EVALUATION. A REVIEW OF THE DEVICE HISTORY RECORD AND UDI ARE IN-PROGRESS. ALL INFORMATION REASONABLY KNOWN AS OF 16 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 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.

    Description of Event or Problem · 0

    IT WAS REPORTED, ¿THEY ACCIDENTALLY WENT INTO THE RIGHT LUNG.¿ PER THE OBSERVING NURSE ON 21NOV2025, ¿I OBSERVED THE PLACEMENT¿ I PROMPTED HIM A COUPLE OF TIMES TO BE AWARE OF RESISTANCE, BUT HE SAID THAT HE DIDN'T NOTICE MUCH. THERE WAS COUGHING INITIALLY PAST THE NASOPHARYNX IN ADDITION TO A LOT OF HIM MOVING HIS HEAD BACK AND FORTH. WE PAUSED FOR SUCTIONING SINCE THERE WERE QUITE A FEW ORAL SECRETIONS IN ADDITION TO THICK SECRETIONS INLINE. THE BEDSIDE NURSE SAID HE HAD BEEN HAVING A BIT OF SECRETIONS. AFTER THE INITIAL PART OF THE INSERTION, I DIDN'T NOTICE ALARMS OR BREATHING ISSUES. WITH THE FINAL ADJUSTMENT, THE TRACING APPEARED TO GO DOWN THE DISPLAY AND THEN IT LOOKED LIKE IT ANGLED TOWARDS THE PYLORUS AND THEN THE MOVEMENT APPEARED TO STOP. WE REMOVED THE GUIDE WIRE; I THEN PUSHED 15 ML OF AIR IN THE TUBE AND REPOSITIONED THE SENSOR. WHEN WE RETRACED THE GUIDE WIRE AND ATTEMPTED TO ADVANCE THE INSERTION AGAIN, THE DISPLAY OF THE TRACING THEN APPEARED TO BE OFF. THE DISTANCE THAT THE TUBE WENT DOWN THE DISPLAY APPEARED SHORTER AND THE POINT WHERE THE TUBE SEEMED TO ANGLE TOWARDS THE PYLORUS HAPPENED SOONER. THERE WAS A FINAL ANGLING BACK TO THE RIGHT ON THE DISPLAY THAT SEEMED SUSPICIOUS, SO I DECIDED TO STOP AND LEAVE THE TUBE WHERE IT WAS AND REMOVE THE GUIDE WIRE.¿ THERE WERE 2 ATTEMPTS. THE RIGHT NARES WAS TRIED FIRST, BUT THAT ATTEMPT DIDN'T APPEAR TO GO PAST THE NASOPHARYNX AND DIDN'T EVEN SHOW UP ON THE DISPLAY. WE THEN ACCESSED THE LEFT NARES. I NOTICED THE TRACING WENT OFF TO THE RIGHT OF THE DISPLAY AND NOT DOWN THE DISPLAY VERY FAR. WE THEN PULLED BACK THE TUBE TO THE NASOPHARYNX FOR AN ADJUSTMENT. WE ADJUSTED ANOTHER TIME WHERE THE DISPLAY APPEARED TO COIL. I BELIEVE WE RETRACED THE GUIDE WIRE 3 TIMES. THERE WERE A COUPLE OF TIMES WHERE I THOUGHT THE DISPLAY TOOK A MOMENT TO CATCH UP TO WHERE WE ACTUALLY WERE WITH THE STYLET AFTER WE RETRACED THE GUIDE WIRE.¿ PER ADDITIONAL INFORMATION RECEIVED ON 25NOV2025, SMALL RIGHT SIDED PNEUMOTHORAX OCCURRED. RIGHT MAINSTEM BRONCHUS THROUGH THE RIGHT LOWER LOBE EXTENDING TO THE SUBPLEURAL SURFACE. A SMALL BORE 10FR CORTRAK TUBE WAS USED. THE PATIENT WAS INTUBATED AT THE TIME OF NASOGASTRIC TUBE PLACEMENT. IT WAS NOTICED IMMEDIATELY AFTER INSERTION WHEN THE CHEST X-RAY WAS OBTAINED. THE TUBE WAS LEFT IN PLACE UNTIL AFTER THE PATIENT WAS EXTUBATED ON (B)(6) 2025. THE TUBE WAS REPLACED ON (B)(6) 2025, BY MD USING FLUOROSCOPY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2197902 CORTRAK 2 ENTERAL ACCESS SYSTEM DH CORTRAK (EAS) KNT AVANOS MEDICAL INC. 20-0950 N/A 00350770007915

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Male Life Threatening| O SRU 2001005 SOFTWARE 2.4.8