BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CORFLO PEG JEJUNAL FEEDING TUBE WITH ENFIT CONNECTOR

    MDR report key: 23034347 · Received September 11, 2025

    Report

    Report Number
    9611594-2025-00207
    Event Type
    Malfunction
    Date Received
    September 11, 2025
    Date of Event
    August 11, 2025
    Report Date
    November 26, 2025
    Manufacturer
    AVANOS MEDICAL INC.
    Product Code
    KNT
    UDI-DI
    00350770462271
    PMA / PMN Number
    K882867
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    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 10-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, 30260046, IN THIS COMPLAINT WAS REVIEWED AND THE MATERIAL WAS PRODUCED ACCORDING TO THE MANUFACTURING PROCEDURES AND MET THE QUALITY REQUIREMENTS. THE SUBJECT SAMPLE WAS RETURNED AND EVALUATED CONFIRMING CLOGGING PRIOR TO FLUSHING DURING DECONTAMINATION, TO FLUSH OUT THE OTHER SIDE OF TUBE (TOWARDS THE DISTAL END) A SYRINGE WITH ENGINEERED FLUID DISPENSING (EFD) TIP WAS USED AND INSERTED AT THE TORN AREA OF TUBE THEN FLUSHING STARTED. OCCLUSION FROM A DARK DRIED SUBSTANCE WAS SEEN, NEAR THE CUT END. THE SUBJECT SAMPLE EVIDENCE NOTED A TUBE WITH TEAR DUE TO THE CLOG ACCORDING TO THE CUSTOMER COMMENTS. THIS 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. HOWEVER, PROCESS ASSESSMENT FOUND NO ACTIVITIES OR TOOLS THAT COULD CAUSE THIS TYPE OF FLAW IN THE TUBE COMPONENT. THE ROOT CAUSE OF THE REPORTED ISSUE SEEMS TO BE A USER RELATED PROBLEM. 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 "THERE WAS AN ISSUE IDENTIFIED WITH THE J-TUBE BEING BLOCKED, ROUTINE ATTEMPTS MADE TO UNBLOCK THE TUBE. DURING A DIAPER CHANGE THE J-TUBE WAS FOUND TO BE PROTRUDING FROM THE RECTUM. J-TUBE WAS INSERTED (B)(6)." ADDITIONAL INFORMATION RECEIVED 15-AUG-2025, NO INJURY OCCURRED FROM THE INCIDENT. THE PATIENT WAS REQUIRED TO BE NPO [NOTHING BY MOUTH] AND HAVE A PERIPHERAL IV [INTRAVENOUS] INSERTED. THE PATIENT ALSO REQUIRED AN X-RAY AND TRIP TO IR [INTERVENTIONAL RADIOLOGY TO GET A NEW TUBE INSERTED. NO CHANGES TO CURRENT STATUS DUE TO THIS INCIDENT. PATIENT REMAINS IN STABLE CONDITION. THE PATIENT WAS ON CONTINUOUS FEEDS ONLY VIA THE NASOJEJUNAL [NJ. THE PATIENT WAS RECEIVING ENFAMIL-A AT 36ML/HR WHICH IS A STANDARD FEED THAT IS NOT CONCENTRATED. THE PATIENT WAS RECEIVING THE FOLLOWING MEDICATIONS WHICH INCLUDED VITAMIN D, OMEPRAZOLE AND IRON. ALL MEDICATIONS WERE LIQUID AND PREPARED BY PHARMACY. THE PATIENT ALSO WAS GIVEN ENZYMES TO UNBLOCK THE TUBE APPROXIMATELY EVERY THREE DAYS. NO STANDARD TUBE FLUSHES WERE ORDERED OR GIVEN, BUT THE PATIENT RECEIVED "FLUSHES POST EVERY MEDICATION ADMINISTRATION." THE FLUSHES WERE ADMINISTERED MANUALLY FOR MEDICATIONS, NORMALLY A 5ML SYRINGE WAS USED, FOR UNBLOCKING BUT THE CLINICIANS DID TRY A 1ML SYRINGE! IN ATTEMPT TO UNCLOG THE DEVICE, "AS PER THE CHARTING A 1 ML SYRINGE WAS DOCUMENTED." THERE WAS NO REPORTED INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    151136 CORFLO PEG JEJUNAL FEEDING TUBE WITH ENFIT CONNECTOR DH CPK JEJUNOSTOMY PRODUCTS KNT AVANOS MEDICAL INC. 50-7366 30260046 00350770462271

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown