BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNKNOWN CORFLO NASOGASTRIC TUBE

    MDR report key: 24562472 · Received March 10, 2026

    Report

    Report Number
    9611594-2026-00120
    Event Type
    Malfunction
    Date Received
    March 10, 2026
    Report Date
    April 23, 2026
    Manufacturer
    AVANOS MEDICAL INC.
    Product Code
    KNT
    PMA / PMN Number
    UNKNOWN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE SAMPLE IS REPORTED TO BE AVAILABLE BUT HAS NOT YET BEEN RECEIVED BY THE MANUFACTURER. A REVIEW OF THE DEVICE HISTORY RECORD IS NOT POSSIBLE AS NO LOT NUMBER WAS PROVIDED; THEREFORE, THE UDI-PI IS UNAVAILABLE. ALL INFORMATION REASONABLY KNOWN AS OF 10 MAR 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.

    Additional Manufacturer Narrative · 0

    THE COMPLAINT WAS EVALUATED BASED ON THE DESCRIPTION AND PROVIDED IMAGE. BREAKAGE IS OBSERVED AT THE Y-PORT TO TUBING JUNCTION. NO EVIDENCE OF MATERIAL OR MANUFACTURING DEFECT IS IDENTIFIED. THE REPEATED OCCURRENCE IN A SINGLE PATIENT ENVIRONMENT, ALONG WITH REPORTED HANDLING AND SECUREMENT PRACTICES, SUGGESTS THE DAMAGE IS CONSISTENT WITH MECHANICAL STRESS (BENDING/TORSION) DURING USE. THE DEVICE IS DESIGNED TO WITHSTAND NORMAL USE CONDITIONS; HOWEVER, EXCESSIVE OR REPEATED STRESS AT CONNECTION POINTS MAY RESULT IN DAMAGE. A ROOT CAUSE COULD NOT BE DETERMINED. ALL INFORMATION REASONABLY KNOWN AS OF 23 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 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

    AVANOS MEDICAL INC. RECEIVED A SINGLE REPORT THAT REFERENCED DIFFERENT INCIDENTS, WHICH WERE ASSOCIATED WITH SEPARATE UNITS, INVOLVING ONE PATIENT. THIS IS THE FIRST OF THREE REPORTS. REFER TO 9611594-2026-00121 FOR THE SECOND REPORT. REFER TO 9611594-2026-00122 FOR THE THIRD REPORT. IT WAS REPORTED, REPEATED BREAKAGE OF THE Y-PORT ON A 6FR CORFLO NASOGASTRIC TUBE. THE Y-PORT SEPARATED AT THE CONNECTION POINT ON THREE SEPARATE OCCASIONS OVER A PERIOD OF LESS THAN FOUR WEEKS OF USE. NO PATIENT INJURY OCCURRED, AND NO MEDICAL INTERVENTION WAS REQUIRED BEYOND ROUTINE TUBE REPLACEMENT. THE FAMILY HAD BEEN SECURING THE TUBE WITH MASKING TAPE. THE USER REPORTED NO DIFFICULTIES WITH INSERTION AND NO USE OF OILS, OIL-BASED MEDICATIONS, OR MCT OIL. A REPLACEMENT 8FR, 91CM TUBE WAS LATER PLACED TO ADDRESS THE ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    439831 UNKNOWN CORFLO NASOGASTRIC TUBE DH CPK NG TUBES KNT AVANOS MEDICAL INC. UNKNOWN ANP

    Patients

    Seq Age Sex Outcome Treatment
    1