BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CORFLO NG/NI FEEDING TUBE WITH STYLET

    MDR report key: 24369458 · Received February 17, 2026

    Report

    Report Number
    9611594-2026-00064
    Event Type
    Malfunction
    Date Received
    February 17, 2026
    Date of Event
    January 15, 2026
    Report Date
    February 17, 2026
    Manufacturer
    AVANOS MEDICAL INC.
    Product Code
    KNT
    UDI-DI
    10350770458134
    PMA / PMN Number
    K821906
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    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 THE REPORTED LOT NUMBER, 30352793, WAS REVIEWED AND DOCUMENTED THAT THE LOT WAS MANUFACTURED ACCORDING TO THE APPROVED MANUFACTURING PROCEDURES, SPECIFICATIONS, AND THEN RELEASED BY QUALITY ASSURANCE. ALL INFORMATION REASONABLY KNOWN AS OF,17-FEB-2036, 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 PIPELINE AND ACCESSORIES ARE FOUND TO BE SEPARATED, AND THE SUSPECTED PRODUCT REASON IS THE INITIAL TREATMENT SITUATION: ALTHOUGH IT IS IN A SEPARATED STATE, IT CAN STILL BE USED AFTER BEING INSERTED, AND IT IS NOT VERY FIRM. SINCE THE GASTROINTESTINAL NUTRITION TUBE HAS JUST BEEN IMPLANTED IN THE BODY, RE-INSERTION OF THE TUBE WILL INCREASE THE PATIENT'S PAIN. SINCE IT CAN BE USED, IT WILL BE CONTINUED AFTER CONSULTATION WITH THE PATIENT'S FAMILY. ADDITIONAL INFORMATION RECEIVED 18-JAN-2026 NOTED THE TUBE HAS SEPARATED FROM THE CONNECTION KIT. THE FITTING CONNECTED TO THE YELLOW HOSE. NO MEDICAL OR SURGICAL INTERVENTION REQUIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    158146 CORFLO NG/NI FEEDING TUBE WITH STYLET DH CPK NG TUBES KNT AVANOS MEDICAL INC. 20-9551 30352793 10350770458134

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Female