BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CORFLO NG/NI FEED TUBE WITH STYLET, ENFIT CONNECTOR

    MDR report key: 24849161 · Received April 11, 2026

    Report

    Report Number
    9611594-2026-00139
    Event Type
    Malfunction
    Date Received
    April 11, 2026
    Report Date
    April 10, 2026
    Manufacturer
    AVANOS MEDICAL INC.
    Product Code
    KNT
    UDI-DI
    00350770460963
    PMA / PMN Number
    K821906
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE HISTORY RECORD FOR THE REPORTED LOT NUMBER: 30192365, IN THIS COMPLAINT WAS REVIEWED AND THE MATERIAL WAS PRODUCED ACCORDING TO THE MANUFACTURING PROCEDURES AND MET THE QUALITY REQUIREMENTS. ONE CORFLO NASOGASTRIC TUBE WAS RECEIVED. PRODUCT PACKAGING WAS NOT RETURNED. THE PRODUCT DOES NOT CONTAIN A LOT NUMBER IDENTIFICATION. THE PRINT ON THE TUBING WAS FADED AND DEGRADED AND COULD NOT BE READ. AFTER CLEANING AND DECONTAMINATION, THE SAMPLE WAS EXAMINED IN A WELL-LIT AREA. THERE IS VISIBLE DAMAGE TO THE TUBING. THERE WAS A ROUGH SURFACE TEXTURE AND SMALL HOLES/TEARS. THIS DAMAGE EXTENDED APPROXIMATELY 3CM FROM THE BASE OF THE Y-ADAPTOR. THE TUBE WAS CUT LATERALLY, JUST BELOW THE Y-ADAPTOR. THEN, ON THE 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. ALL INFORMATION REASONABLY KNOWN AS OF 10-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 THERE WAS A TEAR BETWEEN FROM Y-CONNECTOR AND TUBE AND NUTRITION LEAKED FROM THERE. THERE WAS NO REPORTED INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    910501 CORFLO NG/NI FEED TUBE WITH STYLET, ENFIT CONNECTOR DH CPK NG TUBES KNT AVANOS MEDICAL INC. 42-9438 30192365 00350770460963

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown