BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CORFLO NG/NI FEED TUBE WITH STYLET, ENFIT CONNECTOR

    MDR report key: 24461208 · Received February 26, 2026

    Report

    Report Number
    9611594-2026-00079
    Event Type
    Malfunction
    Date Received
    February 26, 2026
    Date of Event
    January 25, 2026
    Report Date
    February 26, 2026
    Manufacturer
    AVANOS MEDICAL INC.
    Product Code
    KNT
    UDI-DI
    00350770460437
    PMA / PMN Number
    K821906
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE ACTUAL COMPLAINT PRODUCT WAS NOT 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 26-FEB-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 HAD BEEN HAVING INTERMITTENT EMESIS FOR THE PAST THREE DAYS WITH FEEDS. WHEN [THE CLINICIAN] ARRIVED FOR... SHIFT ON 25-JAN-2026 THE PATIENT THREW UP A VERY LARGE AMOUNT OF FORMULA. [THE CLINICIAN] STOPPED THE FEEDS AND GAVE HIS STOMACH A BREAK FOR ABOUT 30 MIN BEFORE GIVING MEDS. WHILE GIVING MEDS HE GAGGED AND THREW UP AFTER ONLY 1 ML BEING GIVEN. GAVE PT ZOFRAN AND TRIED AGAIN WITH WATER AND HE GAGGED AND THREW THAT UP. ATTEMPTED TO VERIFY PLACEMENT BUT WAS UNABLE TO WITH A PH AND UNABLE TO PULL BACK STOMACH CONTENTS. [THE CLINICIAN] DID NOT HEAR ANY CRACKLES OR FLUID IN THE LUNGS AS WELL. ON 24-JAN-2026 THIS HAD HAPPENED AND AFTER ALL THE SAME TROUBLE SHOOTING TECHNIQUES THE CN [CLINICAL NURSE] TOLD ME TO ASK FOR A KUB [KIDNEY, URETERS AND BLADDER]. DUE TO THIS HAPPENING AGAIN ON 1/25 I ASKED FOR A KUB AGAIN AFTER GOING THROUGH THE SAME TROUBLE SHOOTING. TUBE WAS IN THE RIGHT PLACE BASED ON THE KUB ON BOTH DAYS BUT PT NAUSEA WAS MUCH WORSE ON 25-JAN-2026. AFTER REACHING OUT TO THE TEAM I WAS INSTRUCTED TO PUSH MEDS SLOWER TO AVOID EMESIS. PUSHING 3 MEDS THROUGH THE TUBE TOOK AN HOUR AND THE PT THREW THEM UP AT THE END. PUSHED THE REST OF THE MEDS SLOWER THROUGHOUT THE DAY AND PATIENT WOULD GAG AND COUGH BUT NOT THROW THEM UP AS MUCH. AT THE END OF THE SHIFT THE TEAM ASKED [THE CLINICIAN] TO REPLACE THE [PATIENT'S] TUBE WITH ONE THAT IS BIGGER TO AVOID CLOGGING FROM HIS FEEDS ONCE STARTED UP AGAIN. WHEN PULLING OUT THE NG [NASOGASTRIC] TUBE IT HAD BURST AT 42CM." THERE WAS NO REPORTED INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    513627 CORFLO NG/NI FEED TUBE WITH STYLET, ENFIT CONNECTOR DH CPK NG TUBES KNT AVANOS MEDICAL INC. 40-9368 UNKNOPWN 00350770460437

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male