BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CORFLO NASOGASTRIC/NASOINTESTINAL FEEDING TUBES

    MDR report key: 21306099 · Received February 4, 2025

    Report

    Report Number
    9611594-2025-00020
    Event Type
    Malfunction
    Date Received
    February 4, 2025
    Date of Event
    January 5, 2025
    Report Date
    July 11, 2025
    Manufacturer
    AVANOS MEDICAL INC.
    Product Code
    KNT
    UDI-DI
    00350770460468
    PMA / PMN Number
    K821906
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    RISK MANAGER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    A REVIEW OF THE DEVICE HISTORY RECORD IS NOT POSSIBLE AS NO LOT NUMBER WAS PROVIDED; THEREFORE, THE UDI-PI IS UNAVAILABLE. THE PRODUCT INVOLVED IN THE REPORT HAS BEEN RETURNED AND THE INVESTIGATION REMAINS IN PROGRESS AT THIS TIME. ALL INFORMATION REASONABLY KNOWN AS OF (B)(6) 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

    THE ACTUAL COMPLAINT PRODUCT WAS RETURNED FOR EVALUATION. THE SAMPLE DEVICE WAS EXAMINED SHOWING THAT THE TUBING HAD SIGNS OF DAMAGE AND DISCOLORATION. THERE WAS A SPLIT/TEAR IDENTIFIED APPROXIMATELY BETWEEN 42CM AND 40CM. THE TUBING APPEARED TO HAVE EXPANDED TO FORM A BALLOON SHAPE WHICH BURST AXIALLY CAUSING AN OPENING WHICH WILL MAKE THE TUBE UNABLE TO FUNCTION. THE TUBING WAS CUT AND OPENED TO INSPECT THE INNER SURFACE OF TUBING WALLS. FROM 40CM MARKING UNTIL BOLUS END TIP, BROWNISH SUBSTANCE RESIDUES WERE STUCK IN THE TUBE. THE ROOT CAUSE OF THE REPORTED ISSUE SEEMS TO BE A USER RELATED PROBLEM SINCE AS PER THE IFU, VIGOROUS SYRINGE FORCE SHOULD NOT BE USED TO IRRIGATE, ADMINISTER LIQUIDS, OR UNBLOCK THE TUBE. ALL INFORMATION REASONABLY KNOWN AS OF 10 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.

    Description of Event or Problem · 0

    IT WAS REPORTED, ¿DOBHOFF TUBE REQUIRED DE-CLOGGING BETWEEN 5A-6A, LIPASE WAS USED AND THE NURSE WAS ABLE TO DE-CLOG, HOWEVER WHEN SHE WAS FINISHING DE-CLOGGING, SHE NOTED HER NEXT FLUSH WAS VERY DIFFICULT AND SHE WAS CONCERNED THAT THE DOBHOFF TUBE WAS DISPLACED. SO, I ORDERED AN ABDOMINAL X-RAY FOR CONFIRMATION. ABDOMINAL X-RAY REVEALED THAT THE DOBHOFF TUBE WAS FRACTURED IN THE STOMACH AT ABOUT 35 CM ABOVE THE BOTTOM TIP. I REMOVED THE DOBHOFF TUBE PER GASTROINTESTINAL (GI) RECOMMENDATIONS AND WAS ABLE TO RETRIEVE THE ENTIRE TUBE. THE FRACTURE WAS TO THE INTERNAL PORTION OF THE TUBE MAKING IT UNUSABLE, HOWEVER A PORTION OF THE OUTER TUBE (THE FLEXIBLE COVERING) WAS STILL INTACT AND DISTORTED, PRESUMABLY DUE TO EXPANSION DURING FLUSHING.¿ NO HARM TO PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    65198 CORFLO NASOGASTRIC/NASOINTESTINAL FEEDING TUBES DH CPK NG TUBES KNT AVANOS MEDICAL INC. 40-9431 N/A 00350770460468

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown LIPASE.