BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CORFLO NG/NI FEED TUBE WITH STYLET WITH ENFIT CONNECTOR

    MDR report key: 24896453 · Received April 16, 2026

    Report

    Report Number
    9611594-2026-00218
    Event Type
    Malfunction
    Date Received
    April 16, 2026
    Report Date
    April 16, 2026
    Manufacturer
    AVANOS MEDICAL INC.
    Product Code
    KNT
    UDI-DI
    1035077060427
    PMA / PMN Number
    K821906
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE HISTORY RECORD FOR THE REPORTED LOT NUMBER, 30291757, IN THIS COMPLAINT WAS REVIEWED AND THE MATERIAL WAS PRODUCED ACCORDING TO THE MANUFACTURING PROCEDURES AND MET THE QUALITY REQUIREMENTS. THE SAMPLE WAS EVALUATED. NO ORIGINAL PACKAGING RECEIVED. UPON RECEIPT OF THE DEVICE, THE STYLET GUIDEWIRE WAS STILL INTACT INTO THE YELLOW TUBE. CLEANING SOLUTION WAS FLUSHED TO REMOVE THE STYLET GUIDEWIRE FROM THE YELLOW TUBE. AFTER DECONTAMINATION, THE RETURNED SAMPLE DEVICE WAS EXAMINED AND INFUSED WITH WATER SHOWING THAT THE TUBING HAD SIGNS OF DAMAGES (TEAR/HOLE). THERE WERE EXTERNAL DENT MARKS IDENTIFIED AFTER THE SAMPLE WAS INSPECTED UNDER MAGNIFICATION JUST BELOW THE Y-CONNECTOR. THE AREA WHERE THE UNEVEN SURFACE APPEARED WAS JAGGED AND/OR WRINKLED. THE TUBING WAS CUT TO VIEW THE INSIDE SURFACE OF THE TUBING. ONCE THE TUBING WAS OPENED, UNDER MAGNIFICATION, THERE WERE LINES AND INDENTATIONS IN THE INNER WALLS OF THE TUBING. THE STYLET GUIDEWIRE APPEARED BENT IN MULTIPLE LOCATIONS. ROOT CAUSE COULD NOT BE DETERMINED. ALL INFORMATION REASONABLY KNOWN AS OF 15-APR-2026 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 TUBE IS LEAKING BY THE HUB AND WE NOTICED SEVERAL LEAKS/TEARS. PATIENT INJURY DID NOT OCCUR. A NEW TUBE HAD TO BE PLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    955473 CORFLO NG/NI FEED TUBE WITH STYLET WITH ENFIT CONNECTOR DH CPK NG TUBES KNT AVANOS MEDICAL INC. 40-9366 30291757 1035077060427

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown