BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CORFLO NASOGASTRIC/NASOINTESTINAL FEEDING TUBE WITH STYLET WITH ENFIT CONNECTOR

    MDR report key: 25093452 · Received May 6, 2026

    Report

    Report Number
    9611594-2026-00280
    Event Type
    Malfunction
    Date Received
    May 6, 2026
    Date of Event
    May 1, 2025
    Report Date
    May 6, 2026
    Manufacturer
    AVANOS MEDICAL INC.
    Product Code
    KNT
    UDI-DI
    00350770460918
    PMA / PMN Number
    K821906
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    003

    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 30284549 WAS REVIEWED AND THE PRODUCT WAS PRODUCED ACCORDING TO PRODUCT SPECIFICATIONS. THE ACTUAL COMPLAINT PRODUCT WAS RETURNED FOR EVALUATION. JAGGED HOLES WERE OBSERVED ON OPPOSING SIDES OF THE TUBING, JUST BELOW THE BASE OF THE ENFIT CONNECTOR. THE TUBE WAS CUT LATERALLY, BELOW THE ENFIT CONNECTOR. THEN, ON AN OPPOSITE WALL FROM THE TEARS, THE TUBING WAS CUT AXIALLY, IN ORDER TO VIEW THE INNER WALL. THE INNER WALL OF THE TUBING EXHIBITS SIMILAR TEARING AND SURFACE ABRASIONS OR EROSION. A ROOT CAUSE HAS NOT BEEN ESTABLISHED. ALL INFORMATION REASONABLY KNOWN AS OF 06 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 THE INSERTED FEEDING TUBE HAS A HOLE IN THE DISTRIBUTION PIECE. THE CHILD WAS UNDER SEDATION FOR THE INITIAL PLACEMENT, AND THE FEEDING TUBE HAD TO BE INSERTED A SECOND TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    182804 CORFLO NASOGASTRIC/NASOINTESTINAL FEEDING TUBE WITH STYLET WITH ENFIT CONNECTOR DH CPK NG TUBES KNT AVANOS MEDICAL INC. 42-9366 30284549 00350770460918

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown