BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CORFLO NG/NI FEEDING TUBE W/ STYLET W/ ENFIT CONNECTOR

    MDR report key: 22506841 · Received July 15, 2025

    Report

    Report Number
    9611594-2025-00157
    Event Type
    Malfunction
    Date Received
    July 15, 2025
    Date of Event
    June 14, 2025
    Report Date
    September 19, 2025
    Manufacturer
    AVANOS MEDICAL INC.
    Product Code
    KNT
    UDI-DI
    00350770460823
    PMA / PMN Number
    K821906
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    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 LOT 30321738 WAS REVIEWED AND THE PRODUCT WAS PRODUCED ACCORDING TO PRODUCT SPECIFICATIONS. A REVIEW OF THE UDI IS IN-PROGRESS. ALL INFORMATION REASONABLY KNOWN AS OF 14 JUL 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 REPORTED EVENT BUT IS RELAYING THE INFORMATION PROVIDED BY THE USER FACILITY WHERE THE INCIDENT OCCURRED. THIS PRODUCT INCIDENT IS DOCUMENTED IN THE AVANOS MEDICAL 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

    ADDITIONAL INFORMATION: D4. ALL INFORMATION REASONABLY KNOWN AS OF 19-SEP-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 REPORTED EVENT BUT IS RELAYING THE INFORMATION PROVIDED BY THE USER FACILITY WHERE THE INCIDENT OCCURRED. THIS PRODUCT INCIDENT IS DOCUMENTED IN THE AVANOS MEDICAL 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 NJT [NASOJEJUNAL TUBE] (8FR) INSERTED ON (B)(6) 2025 INITIALLY AT 60CM. ADVANCE BY 5CM TO 65CM BASED ON IN INITIAL X-RAY POST INITIAL INSERTION ON (B)(6) 2025. HAD BEEN USED FOR FEEDING WITH NIL CONCERNS UNTIL (B)(6) 2025 PM WHEN NOTED TO HAVE MILKY ASPIRATED FROM NGT [NASOGASTRIC TUBE]. PATIENT CHECKED FOR NGT /NJT POSITION BY OPENING OF MOUTH TO SEE IF FEEDING TUBE HAD CURLED BACK-UP. IT WAS THEN NOTED THAT THE NJT WAS NOT VISIBLE IN BACK OF MOUTH/THROAT, EXCEPT FOR THE NGT WHICH WAS VISIBLE AND PRESENT. PATIENT HAD CHEST AND ABDO [ABDOMINAL] X-RAY WHICH SHOWED NJT HAD BROKEN, WITH THE OTHER HALF POSITIONED FROM UNDER CLAVICLE. THE NJT WAS THEN REMOVED AND APPEARS TO SNAP/BROKE AT 61CM. SURGEONS WERE REPORTED CONTACTED FOR ADVICE. THEY INFORMED THE PCCU [PEDIATRIC CRITICAL CARE UNIT] TEAM TO REMOVE THE NGT AS THE NJT MAY BE CURLED/TANGLE AGAINST IT. NGT REMOVED, BUT REMAINDER OF THE NJT WAS NOT FOUND. NEW NGT INSERTED ON (B)(6) 2025. REFERRED TO SURGEONS FOR REMOVAL SURGICALLY AS APPEARS TO HAVE NOT MIGRATED FURTHER DOWNWARDS/UPWARDS AFTER 24HRS.¿ PER ADDITIONAL INFORMATION RECEIVED ON 20JUN2025, "THE NJT WAS ENDOSCOPICALLY REMOVED SUCCESSFULLY ON THE (B)(6). THE PATIENT IS CURRENTLY STABLE, HOWEVER HAD 24HRS POST-OP, WHERE HE WAS BELOW HIS BASELINE PREOP, I.E NEW OXYGEN REQUIREMENT AND INCREASED SECRETION LOAD. THE PATIENT REQUIRED ADDITION CHEST PHYSIOTHERAPY DURING THE 24HRS FOLLOWING THE RETRIEVAL OF THE SNAPPED NJT. THE POTENTIAL NEGATIVE CONSEQUENCE AT THE MOMENT IS DELAYED DISCHARGE, DELAYED NUTRITION ¿ AS ENTERAL FEEDING IS BEING RE-GRADED SLOWLY."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    153688 CORFLO NG/NI FEEDING TUBE W/ STYLET W/ ENFIT CONNECTOR DH CPK NG TUBES KNT AVANOS MEDICAL INC. 42-7368 30321738 00350770460823

    Patients

    Seq Age Sex Outcome Treatment
    1 6 YR Male