BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CORFLO NG/NI FEEDING TUBE WITH STYLET WITH ENFIT CONNECTOR

    MDR report key: 22292939 · Received June 19, 2025

    Report

    Report Number
    9611594-2025-00128
    Event Type
    Malfunction
    Date Received
    June 19, 2025
    Date of Event
    May 18, 2025
    Report Date
    June 19, 2025
    Manufacturer
    AVANOS MEDICAL INC.
    Product Code
    KNT
    UDI-DI
    00350770460482
    PMA / PMN Number
    K821906
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    003

    Narratives

    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 19-JUN-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 "PATIENT FEEDING TUBE WAS CLOGGED, RN [REGISTERED NURSE] FOLLOWED UNCLOGGING PROCEDURES. WHEN RN WENT TO FLUSH TO RESTART FEEDING TUBE IT WAS NOTED THE FLUSHING FLUID COMING OUT OF PATIENT MOUTH. WHEN FEEDING TUBE REMOVED ONLY A SMALL PORTION OR ABOUT 10 CM CAME OUT, THE END HAD THE APPEARANCE OF A BURST TUBE WITH A SIGNIFICANT AMOUNT WAS REMAINING INSIDE PATIENT. THE PATIENT REQUIRED 2 CHEST X-RAYS AND THEN REMOVAL OF THE FEEDING TUBE BY USING FORCEPS TO GRAB THE TUBE. NO FURTHER PATIENT HARM REPORTED. " ADDITIONAL INFORMATION RECEIVED 29-MAY-2025 STATED THE DEVICE WAS INSERTED (B)(6) 2025 AND WAS REMOVED FOLLOWING THIS INCIDENT ON (B)(6) 2025. THERE WAS NO DIFFICULTY NOTED DURING INSERTION OF THE DEVICE. THE FEEDINGS WERE CONTINUOUS. THE FEEDINGS WERE PAUSED FOR THREE WEEKS FOR DIALYSIS APPOINTMENTS, APPROXIMATELY, 4-HOURS EACH TIME. THE FEEDING SOLUTION WAS NOVASOURCE RENAL SOLUTION. THE DEVICE WAS USED FOR CRUSHED ORAL AND LIQUID MEDICATION ADMINISTRATION FREQUENTLY. THE TUBE WAS FLUSHED WITH 30ML OF WATER EVERY 4-HOURS, AS WELL AS BEFORE AND AFTER ANY MEDICATIONS WERE INSTILLED. THE TUBE WAS FLUSHED MANUALLY WITH A SYRINGE. THE SYRINGE SIZES USED FOR FLUSHING WERE 50ML OR 60ML. DURING THE FIRST ATTEMPT TO UNCLOG THE TUBE THE CLINICIAN USED 3ML OF WARM WATER IN A 3ML SYRINGE, THIS ATTEMPT WAS NOT EFFECTIVE IN THIS CASE. NEXT THE CLINICIAN CRUSHED ONE UNCOATED COTAZYM (PANCREATIC ENZYME) TABLET AND ONE 300MG SODIUM BICARBONATE TABLET AND MIX UNTIL COMPLETELY DISSOLVED IN 30ML OF WARM WATER IN A 30ML SYRINGE. AN ATTEMPT WAS MADE TO SUCTION EVERYTHING FROM THE TUBE BEFORE INSTILLING THE MIXTURE. THE CLINICIAN LET THE SOLUTION SIT FOR 20-MINUTES BEFORE ATTEMPTING TO FLUSH AGAIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    852837 CORFLO NG/NI FEEDING TUBE WITH STYLET WITH ENFIT CONNECTOR DH CPK NG TUBES KNT AVANOS MEDICAL INC. 40-9432 UNKNOWN 00350770460482

    Patients

    Seq Age Sex Outcome Treatment
    1 40 YR Male