BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CORFLO NASOGASTRIC/NASOINTESTINAL FEEDING TUBES

    MDR report key: 24621306 · Received March 17, 2026

    Report

    Report Number
    9611594-2026-00134
    Event Type
    Malfunction
    Date Received
    March 17, 2026
    Date of Event
    December 13, 2025
    Report Date
    March 17, 2026
    Manufacturer
    AVANOS MEDICAL INC.
    Product Code
    KNT
    UDI-DI
    00350770460338
    PMA / PMN Number
    K821906
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE ACTUAL COMPLAINT PRODUCT WAS NOT RETURNED FOR EVALUATION. THE DEVICE HISTORY RECORD FOR LOT 30380528 WAS REVIEWED AND THE PRODUCT WAS PRODUCED ACCORDING TO PRODUCT SPECIFICATIONS. A ROOT CAUSE COULD NOT BE DETERMINED. ALL INFORMATION REASONABLY KNOWN AS OF 17 MAR 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 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 VIA FDA MEDWATCH MW5182520, ¿DURING ATTEMPT TO INSERT AN AVANOS CORFLO NASOGASTRIC/NASOINTESTINAL FEEDING TUBE, NURSE EXPERIENCED DIFFICULTY ADVANCING THE TUBE PAST THE ET (ENDOTRACHEAL TUBE) TUBE. WHEN UNSUCCESSFUL ADVANCEMENT WAS APPARENT, THE TUBE WAS PULLED OUT, THE YELLOW TIP OF THE TUBE WAS MISSING. STAT X-RAY CONFIRMED THE TIP WAS LODGED IN THE PATIENT'S THROAT, REQUIRING REMOVAL VIA BRONCHOSCOPY, WHICH THE PATIENT HAD TO GO FOR ANYWAY TO CLEAR OUT COPIOUS SECRETIONS OF BOTH RIGHT AND LEFT BRONCHIAL LOBES FROM ASPIRATION.¿

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    417503 CORFLO NASOGASTRIC/NASOINTESTINAL FEEDING TUBES DH CPK NG TUBES KNT AVANOS MEDICAL INC. 40-7432 30380528 00350770460338

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown