BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CORFLO NG/NI FEED TUBE WITH STYLET, ENFIT CONNECTOR

    MDR report key: 25306983 · Received May 27, 2026

    Report

    Report Number
    9611594-2026-00371
    Event Type
    Malfunction
    Date Received
    May 27, 2026
    Date of Event
    April 1, 2026
    Report Date
    May 27, 2026
    Manufacturer
    AVANOS MEDICAL INC.
    Product Code
    KNT
    UDI-DI
    00350770460307
    PMA / PMN Number
    K821906
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE ACTUAL COMPLAINT PRODUCT WAS 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 27-MAY-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 PATIENT'S NASOGASTRIC "TUBE SOMEHOW BROKE OFF WHILE IN HER GI TRACT. [PATIENT] PULLED OUT HER...DURING HER BATH AND WHEN TRYING TO PLACE A NEW ONE, X-RAY'S APPEARED AS THOUGH IT WAS COILING IN HER PYLORUS. PER PROVIDERS REVIEW OKAY TO RESTART FEEDS AND MEDS AFTER PULLING A FEW CM BACK. A FEW HOURS LATER THE RADIOLOGIST CALLED THE PROVIDER AND STATED THAT THERE APPEARS TO BE A FRACTURED PIECE OF A TUBE IN THE STOMACH CROSSING INTO THE DUODENUM." THERE WAS NO REPORTED INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    89330 CORFLO NG/NI FEED TUBE WITH STYLET, ENFIT CONNECTOR DH CPK NG TUBES KNT AVANOS MEDICAL INC. 40-7366 UNKNOWN 00350770460307

    Patients

    Seq Age Sex Outcome Treatment
    1