BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CORFLO NG/NI FEED TUBE WITH STYLET, ENFIT CONNECTOR

    MDR report key: 25322507 · Received May 28, 2026

    Report

    Report Number
    9611594-2026-00372
    Event Type
    Malfunction
    Date Received
    May 28, 2026
    Date of Event
    April 17, 2026
    Report Date
    May 28, 2026
    Manufacturer
    AVANOS MEDICAL INC.
    Product Code
    KNT
    UDI-DI
    00350770460420
    PMA / PMN Number
    K821906
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE ACTUAL COMPLAINT PRODUCT WAS RETURNED FOR EVALUATION. REVIEW OF THE DEVICE HISTORY RECORD FOR THE PROVIDED IS IN-PROGRESS. ALL INFORMATION REASONABLY KNOWN AS OF (B)(6) 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 TUBE WAS PLACED ON (B)(6) 2026. THE PORT DETACHED AT HOME ON (B)(6) 2026. THE PATIENT WAS ADMITTED TO THE HOSPITAL FOR TUBE AND BRIDLE REPLACEMENT. THE PATIENT REQUIRED ANESTHESIA FOR REPLACEMENT IN INTERVENTIONAL RADIOLOGY. PATIENT COMPLEX NEEDS, HIGH RISK WITH ANESTHESIA. THE PATIENT WAS EVENTUALLY DISCHARGED TO HOME. THERE WAS NO REPORTED INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    545987 CORFLO NG/NI FEED TUBE WITH STYLET, ENFIT CONNECTOR DH CPK NG TUBES KNT AVANOS MEDICAL INC. 40-9366 30388263 00350770460420

    Patients

    Seq Age Sex Outcome Treatment
    1