BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CORFLO NG/NI FEEDING TUBE WITH STYLET, ENFIT CONNECTOR

    MDR report key: 23384077 · Received October 24, 2025

    Report

    Report Number
    9611594-2025-00249
    Event Type
    Malfunction
    Date Received
    October 24, 2025
    Date of Event
    September 14, 2025
    Report Date
    December 30, 2025
    Manufacturer
    AVANOS MEDICAL INC.
    Product Code
    KNT
    UDI-DI
    00350770460314
    PMA / PMN Number
    K821906
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE ALLEGED SAMPLE DEVICE WAS RETURNED WITHOUT THE ORIGINAL PACKAGING. PRIOR TO DECONTAMINATION, THE SAMPLE WAS PHOTOGRAPHED TO SHOW THE APPEARANCE HOW IT WAS RECEIVED. THE SAMPLE DEVICE WAS EXAMINED SHOWING THAT THE TUBING HAD SIGNS OF DAMAGE AND DISCOLORATION. DURING CLEANING AND DECONTAMINATION, SOME BUILD-UP/ DISCOLORATION FROM THE OUTER TUBING WAS TRIED TO BE REMOVE BY SCRUBBING THE TUBING WITH LINT FREE TOWEL USING TERGAZYME AND SOAKED IN METRICIDE SOLUTION. THE TUBE WAS ALSO FLUSHED THROUGH THE Y-CONNECTOR (PROXIMAL END). NO RESISTANCE WAS FELT DURING FLUSHING THE PROXIMAL SIDE OF TUBE WHILE THE DISTAL SIDE OF TUBE EXHIBITED SLIGHT RESISTANCE BUT EVENTUALLY SOME LIGHT BROWNISH CREAMY SUBSTANCES WERE FLUSHED OUT OF THE TUBE AFTER COUPLE ATTEMPTS. THERE WAS A SPLIT/TEAR IDENTIFIED APPROXIMATELY AT THE 26CM MARKING. SOME BLACKISH DISCOLORATION WAS SPOTTED IN DIFFERENT LOCATIONS ON THE TUBE. AT THE 26CM MARKED LOCATION, THE TUBING APPEARED TO HAVE EXPANDED TO FORM A BALLOON SHAPE WHICH BURST AXIALLY. WHEN MANUALLY PRESSING THE TUBING BACK TOGETHER, THERE WERE THIN LAYERS OF THE MATERIAL NOTICED ON THE BALLOONED PORTION OF THE TUBE. THE REPORTED KINKING OF TUBE WAS ALSO OBSERVED AT 22CM MARKING ON TUBE. THE STYLET GUIDEWIRE WAS OBSERVED TO HAVE BENT IN MULTIPLE AREAS. ROOT CAUSE COULD NOT BE DETERMINED. ALL INFORMATION REASONABLY KNOWN AS OF 30-DEC-2025 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.

    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 24-OCT-2025 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 "ATTEMPTED TO GET PH FROM [NASOGASTRIC] NG TUBE AT 1400-HOURS PRIOR TO MEDICATION ADMINISTRATION. UNABLE TO GET ASPIRATE. REPOSITIONED PATIENT HAD SECOND [REGISTERED NURSE] RN ATTEMPT TO GET PH AND RETAPED NG TUBE, STILL UNABLE TO GET PH. [MEDICAL DOCTOR] MD NOTIFIED...CHEST X-RAY DONE. KINK IN NG TUBING SEEN ON X-RAY. NG TUBE REMOVED, TEAR IN TUBING NOTED. NEW NG TUBE INSERTED, GOT ASPIRATE PH OF 2, NG TUBE NOW IN USE AGAIN." THERE WAS NO REPORTED INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1703667 CORFLO NG/NI FEEDING TUBE WITH STYLET, ENFIT CONNECTOR DH CPK NG TUBES KNT AVANOS MEDICAL INC. 40-7368 UNKNOWN 00350770460314

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown