BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CORFLO NASOGASTRIC/NASOINTESTINAL PEDIATRIC FEEDING TUBE

    MDR report key: 25229294 · Received May 20, 2026

    Report

    Report Number
    9611594-2026-00320
    Event Type
    Malfunction
    Date Received
    May 20, 2026
    Report Date
    May 20, 2026
    Manufacturer
    AVANOS MEDICAL INC.
    Product Code
    KNT
    UDI-DI
    00350770460369
    PMA / PMN Number
    K831328
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    HI, US
    Reporter Occupation
    PHARMACIST
    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. THE DEVICE HISTORY RECORD FOR LOT 30282235 WAS REVIEWED AND THE PRODUCT WAS PRODUCED ACCORDING TO PRODUCT SPECIFICATIONS. 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) JUST INSIDE THE Y-CONNECTOR DISTAL END. THERE WERE EXTERNAL DENT MARKS IDENTIFIED AS WELL AFTER THE SAMPLE WAS INSPECTED UNDER MAGNIFICATION INSIDE THE Y-CONNECTOR. THE AREA WHERE THE UNEVEN SURFACE APPEARED JAGGED AND/OR WRINKLED. THE TUBING WAS THEN CUT TO VIEW THE INSIDE SURFACE OF THE TUBING. ONCE THE TUBING WAS OPENED, UNDER MAGNIFICATION (50X), THERE WERE LINES AND INDENTATIONS IN THE INNER WALLS OF THE TUBING WERE SEEN. A ROOT CAUSE HAS NOT BEEN ESTABLISHED. ALL INFORMATION REASONABLY KNOWN AS OF 18 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 AN NG TUBE LEAKED AT THE BASE UPON INSERTION, AND THE DEVICE WAS REMOVED. NO INJURY OR MEDICAL INTERVENTION WAS REPORTED. EVENT DATE UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    301333 CORFLO NASOGASTRIC/NASOINTESTINAL PEDIATRIC FEEDING TUBE DH CPK NG TUBES KNT AVANOS MEDICAL INC. 40-8366 30282235 00350770460369

    Patients

    Seq Age Sex Outcome Treatment
    1