BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CORFLO NG/NI FEEDING TUBE WITH STYLET WITH ENFIT CONNECTOR

    MDR report key: 23193046 · Received October 1, 2025

    Report

    Report Number
    9611594-2025-00225
    Event Type
    Injury
    Date Received
    October 1, 2025
    Date of Event
    August 25, 2025
    Report Date
    November 26, 2025
    Manufacturer
    AVANOS MEDICAL INC.
    Product Code
    KNT
    UDI-DI
    00350770460505
    PMA / PMN Number
    K821906
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE SAMPLE IS REPORTEDLY AVAILABLE FOR THIS COMPLAINT BUT WAS NOT RETURNED WHEN THIS REPORT WAS FILED. A REVIEW OF THE DEVICE HISTORY RECORD AND UDI NUMBER ARE IN-PROGRESS. 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 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 DEVICE HISTORY RECORD FOR THE REPORTED LOT NUMBER, 30301297, IN THIS COMPLAINT WAS REVIEWED AND THE MATERIAL WAS PRODUCED ACCORDING TO THE MANUFACTURING PROCEDURES AND MET THE QUALITY REQUIREMENTS. THE SUBJECT SAMPLE PROVIDED WAS EVALUATED CONFIRMING A BALLOONING AREA WITH AN AXIAL SPLIT LOCATED APPROXIMATELY AT THE 38CM MARKING. AT THE 38CM MARKED LOCATION, THE TUBING APPEARED TO HAVE EXPANDED TO FORM A BALLOON SHAPE WHICH BURST IN MULTIPLE DIRECTION CAUSING A SEPARATION OF THE TUBE INTO TWO PIECES. AT THE DISTAL END OF THE TUBE RESISTANCE WAS FELT AND EVENTUALLY CREAMY YELLOWISH SUBSTANCES WERE FLUSH OUT AFTER COUPLE ATTEMPTS. THE ROOT CAUSE OF THE REPORTED ISSUE SEEMS TO BE A USER RELATED PROBLEM SINCE AS PER THE INSTRUCTIONS FOR USE (IFU), VIGOROUS SYRINGE FORCE SHOULD NOT BE USED TO IRRIGATE, ADMINISTER LIQUIDS, OR UNBLOCK THE TUBE. ALL INFORMATION REASONABLY KNOWN AS OF 26-NOV-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 THE "NJT [NASOJEJUNAL TUBE WAS] BLOCKED SINCE 0600. ATTEMPTED TO UNBLOCK WITH ENZYMES AS PER POLICY AT 1230 WITH NO LUCK, MET WITH...RESISTANCE AND CAUSING A NOTICEABLE AMOUNT OF DISCOMFORT TO PATIENT. PATIENT THEN TAKEN TO STAT ULTRASOUNDS TO RULE OUT INTUSSUSCEPTION AS PER NP (NURSE PRACTIONER). ONCE BACK IN ROOM AT APPROXIMATELY 1500 PATIENT IRRITABLE AND SNEEZING, [THE REPORTER] ATTEMPTED TO NASAL TIP SUCTION THE SECRETIONS/SNOT AROUND NOSE AND NJT. NJT BEGAN POKING OUT NEAR THE NARE/NASAL BRIDLE (SECUREMENT DEVICE), AT CLOSER LOOK WRITER NOTED THE NJ TUBING APPEARED TO BE TORN/SPLIT OPEN; NP NOTIFIED AND CAME IN ROOM TO ASSESS. BRIDLE THEN CUT BY WRITER AND AS THE NJT WAS BEING REMOVED THE TUBE BROKE INTO 2 PIECES, BUT BOTH PIECES BEING ABLE TO BE FULLY REMOVED FROM PATIENT. THERE WAS NO REPORTED INJURY. ADDITIONAL INFORMATION RECEIVED 08-SEP-2025 NOTED THE TUBE WAS IN PLACE FOR 10-DAYS (INSERTED AUGUST 15 AND REMOVED AUGUST 25). THE PATIENT WAS RECEIVING CONTINUOUS FEEDINGS RUNNING AT 40ML/HOUR FOR 18-HOURS. NONE OF THE FEEDINGS CONSISTED OF BLENDED FEEDS NOR THICK CONSISTENCY FORMULAS. ORAL AND CRUSHED MEDICATIONS WERE USED IN THE DEVICE. THERE WERE NO OILS NOR OIL-BASED MEDICATIONS INFUSED IN THE DEVICE. THE DEVICE WAS LUSHED MANUALLY WITH WATER 20ML FLUSHES EVERY 4-HOURS AT 0000, 0400, 08, 1200, 1600, 2000 AND ADDITIONALLY SIX TIMES WITH MEDICATION FLUSHES USING SYRINGES. MULTIPLE SIZE SYRINGES WERE USED ON THE DEVICE INCLUDING 1 ML, 3 ML, 10 ML, AND 20 ML.. DURING THE UNCLOGGING ATTEMPT A 1 ML AND 3 ML SIZE SYRINGE WERE USED. THE PATIENT REQUIRED NEW NJ TUBE INSERTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2015665 CORFLO NG/NI FEEDING TUBE WITH STYLET WITH ENFIT CONNECTOR DH CPK NG TUBES KNT AVANOS MEDICAL INC. 40-9438 30301297 00350770460505

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown