BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNKNOWN CORTRAK NASOGASTRIC TUBE

    MDR report key: 25128756 · Received May 8, 2026

    Report

    Report Number
    9611594-2026-00293
    Event Type
    Malfunction
    Date Received
    May 8, 2026
    Date of Event
    February 13, 2025
    Report Date
    May 8, 2026
    Manufacturer
    AVANOS MEDICAL INC.
    Product Code
    KNT
    UDI-DI
    00350770009094
    PMA / PMN Number
    UNKNOWN
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    RISK MANAGER
    Health Professional
    N

    Narratives

    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. THE LOT NUMBER WAS NOT PROVIDED BY THE CUSTOMER. ALL INFORMATION REASONABLY KNOWN AS OF 08-MAY-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 VIA FDA MEDWATCH / FDA USER FACILITY REPORT MW REPORT 22935951 THE FOLLOWING INFORMATION: "A 75-YEAR-OLD MALE WAS ADMITTED FOR SEPSIS COMPLICATED BY SEVERE SELF-CARE DEFICIT AND A BMI OF 13. THE PATIENT REQUIRED A FEEDING TUBE TO BE PLACED FOR NUTRITION. AFTER PLACEMENT OF THE FEEDING TUBE, TUBE FEEDS WERE STARTED. THE PATIENT WAS NOTED TO HAVE INCREASED OXYGEN REQUIREMENTS FOR WHICH HIGH FLOW NASAL CANNULA SETTINGS WERE INCREASED. A CHEST X-RAY WAS COMPLETED AND SHOWED THE FEEDING TUBE TERMINATING IN THE PATIENT'S RIGHT LUNG, AND NEW OPACITIES IN THE BASE OF THE RIGHT LUNG. THE FEEDING TUBE WAS DISCONTINUED, AND A NEW FEEDING TUBE PLACED WITH X-RAY CONFIRMATION OF PLACEMENT IN THE STOMACH."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    379671 UNKNOWN CORTRAK NASOGASTRIC TUBE DH CORTRAK DISPOSABLES KNT AVANOS MEDICAL INC. UNKNOWN UNKNOWN 00350770009094

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Male Other