BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CORFLO NG/NI FEEDING TUBE WITH STYLET, ENFIT CONNECTOR

    MDR report key: 24380486 · Received February 18, 2026

    Report

    Report Number
    9611594-2026-00066
    Event Type
    Malfunction
    Date Received
    February 18, 2026
    Date of Event
    January 2, 2026
    Report Date
    February 18, 2026
    Manufacturer
    AVANOS MEDICAL INC.
    Product Code
    KNT
    UDI-DI
    00350770460338
    PMA / PMN Number
    K821906
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO
    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, 30366991, IN THIS COMPLAINT WAS REVIEWED AND THE MATERIAL WAS PRODUCED ACCORDING TO THE MANUFACTURING PROCEDURES AND MET THE QUALITY REQUIREMENTS. ALL INFORMATION REASONABLY KNOWN AS OF 17-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 21 CFR 803, 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 PROBE WAS, PASSED UNDER ENDOSCOPY, WHEN PERFORMING PERMEABILITY CHECK IS OBSERVED ORIFICE OUTLET, PERFORATED PROBE. THERE WAS NO REPORTED PATIENT INJURY. ADDITIONAL INFORMATION RECEIVED ON 27-JAN-2026 STATING THE PERFORATION OCCURRED OUTSIDE OF THE PATIENT, APPROXIMATELY AT THE 1-CM MARK OF THE 'Y' CONNECTOR. THE DEVICE WAS NOT RETAINED INSIDE OF THE PATIENT. MEDICAL INTERVENTION WAS NOT REQUIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    441925 CORFLO NG/NI FEEDING TUBE WITH STYLET, ENFIT CONNECTOR DH CPK NG TUBES KNT AVANOS MEDICAL INC. 40-7432 30366991 00350770460338

    Patients

    Seq Age Sex Outcome Treatment
    1 17 YR Female