BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CORFLO NASOGASTRIC/NASOINTESTINAL FEEDING TUBE WITH STYLET WITH ENFIT CONNECTOR

    MDR report key: 25137467 · Received May 11, 2026

    Report

    Report Number
    9611594-2026-00302
    Event Type
    Malfunction
    Date Received
    May 11, 2026
    Date of Event
    August 21, 2025
    Report Date
    May 11, 2026
    Manufacturer
    AVANOS MEDICAL INC.
    Product Code
    KNT
    UDI-DI
    00350770460802
    PMA / PMN Number
    UNKNNOWN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    EI
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THIS EVENT WAS INITIALLY DEEMED NOT REPORTABLE BASED ON OUR REPORTING STRATEGY ACTIVE AT THE TIME OF THE ALERT DATE; HOWEVER, FOLLOWING A RECENT RETROSPECTIVE REVIEW OF COMPLAINTS THIS EVENT WAS MADE REPORTABLE OUT OF AN ABUNDANCE OF CAUTION. A REVIEW OF THE DEVICE HISTORY RECORD IS NOT POSSIBLE AS NO LOT NUMBER WAS PROVIDED; THEREFORE, THE UDI-PI IS UNAVAILABLE. THE ACTUAL COMPLAINT PRODUCT WAS RETURNED FOR EVALUATION. THE RETURNED SAMPLE DEVICE WAS EXAMINED AND INFUSED WITH WATER SHOWING THAT THE TUBING HAD SIGNS OF DAMAGES (TEAR/ HOLE/ CUT) AND THEN LEAKAGE. THERE WAS EXTERNAL DENT MARK IDENTIFIED AFTER THE SAMPLE WAS INSPECTED UNDER MAGNIFICATION, JUST BELOW THE Y CONNECTOR. THE AREA WHERE THE UNEVEN SURFACE IS APPEARED SLIGHTLY JAGGED. THE TUBING WAS CUT TO VIEW THE INSIDE SURFACE. ONCE THE TUBING WAS OPENED, THERE WERE NO LINES AND INDENTATIONS IN THE INNER WALLS OF THE TUBING. THE OUTER SURFACE OF THE TUBE EXHIBITED SLIGHT JAGGED APPEARANCE WHILE THE INNER SURFACE APPEARED SMOOTH. A ROOT CAUSE HAS NOT BEEN ESTABLISHED. ALL INFORMATION REASONABLY KNOWN AS OF 11 MAY 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 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 THAT A NASOGASTRIC TUBE WAS PLACED ON (B)(6) 2025. TUBE FOUND TO BE LEAKING ON 21-AUG-2025. A SMALL TEAR WAS IDENTIFIED JUST ABOVE THE FEEDING PORT WHEN ADMINISTERING MEDICATION. FEED WAS STOPPED AS A RESULT AND THE TUBE WAS REMOVED (B)(6) 2025.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    462260 CORFLO NASOGASTRIC/NASOINTESTINAL FEEDING TUBE WITH STYLET WITH ENFIT CONNECTOR DH CPK NG TUBES KNT AVANOS MEDICAL INC. 42-7361 UNKNOWN 00350770460802

    Patients

    Seq Age Sex Outcome Treatment
    1 83 YR Female