BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CORFLO NI ENDOSCOPICALLY PLACED FEEDING TUBE

    MDR report key: 24903769 · Received April 16, 2026

    Report

    Report Number
    9611594-2026-00211
    Event Type
    Malfunction
    Date Received
    April 16, 2026
    Report Date
    April 16, 2026
    Manufacturer
    AVANOS MEDICAL INC.
    Product Code
    KNT
    UDI-DI
    00350770462325
    PMA / PMN Number
    K882867
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE HISTORY RECORD FOR THE REPORTED LOT NUMBER: 30252010, IN THIS COMPLAINT WAS REVIEWED AND THE MATERIAL WAS PRODUCED ACCORDING TO THE MANUFACTURING PROCEDURES AND MET THE QUALITY REQUIREMENTS. THE SAMPLE WAS RECEIVED WITH AN OPENED ORIGINAL PACKAGING. A GUIDEWIRE, EXTRA YELLOW TUBING WITHOUT MARKINGS AND THE ENFIT YELLOW TUBING THAT APPEARED TO HAVE SOME SORT OF DAMAGE JUST BELOW THE Y-CONNECTOR PORT. UPON RECEIPT THE YELLOW TUBING WITH THE ENFIT CONNECTOR PORT WAS EXAMINED AND OBSERVED TO HAVE SPLITTING JUST BELOW THE Y-CONNECTOR PORT. THE TUBE WAS EXAMINED UNDER MAGNIFICATION; THERE WAS A PARTIAL SPLITTING IDENTIFIED BELOW THE Y-CONNECTOR. THE AREA WHERE THE SPLIT LOCATED APPEARED TO HAVE JAGGED APPEARANCE. ROOT CAUSE COULD NOT BE DETERMINED. ALL INFORMATION REASONABLY KNOWN AS OF 14-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 "WHEN RINSING THE CORFLO PROBE (WITH WATER), IT TURNED OUT THAT THERE WAS A CRACK IN THE PROBE, JUST BELOW THE Y-POINT. THIS MADE THIS PROBE UNUSABLE." THERE WAS NO REPORTED INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    963410 CORFLO NI ENDOSCOPICALLY PLACED FEEDING TUBE DH CPK NI (NASOINTESTINAL) FEEDING TUBES KNT AVANOS MEDICAL INC. 51-9601 30252010 00350770462325

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown