BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CORFLO NASOGASTRIC / NASOINTESTINAL FEEDING TUBE

    MDR report key: 25255580 · Received May 22, 2026

    Report

    Report Number
    9611594-2026-00349
    Event Type
    Malfunction
    Date Received
    May 22, 2026
    Date of Event
    September 11, 2023
    Report Date
    May 22, 2026
    Manufacturer
    AVANOS MEDICAL INC.
    Product Code
    KNT
    UDI-DI
    00350770457991
    PMA / PMN Number
    K821906
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    NURSE
    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 REVIEW FOR LOT 30133122 CONFIRMED THE PRODUCT WAS MANUFACTURED ACCORDING TO APPROVED MANUFACTURING PROCEDURES AND SPECIFICATIONS, WITH NO NONCONFORMANCES, CAPAS, ABNORMAL CONDITIONS, OR PROCESS DEVIATIONS IDENTIFIED. SAMPLE WAS NOT RETURNED FOR EVALUATION; THEREFORE, FUNCTIONAL TESTING COULD NOT BE PERFORMED TO CONFIRM OR DUPLICATE THE REPORTED CLOGGING CONDITION. ROOT CAUSE COULD NOT BE DETERMINED. WITHOUT A RETURNED SAMPLE, THE REPORTED CLOGGING CONDITION COULD NOT BE CONFIRMED THROUGH FUNCTIONAL EVALUATION. ALL INFORMATION REASONABLY KNOWN AS OF 21 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

    AVANOS MEDICAL INC. RECEIVED A SINGLE REPORT THAT REFERENCED DIFFERENT INCIDENTS, WHICH WERE ASSOCIATED WITH SEPARATE UNITS. THIS IS THE FIRST OF THREE REPORTS. FOR THE FIRST REPORT, REFER TO 9611594-2026-00350 FOR THE SECOND REPORT, REFER TO 9611594-2026-00351 FOR THE THIRD REPORT. THE CUSTOMER REPORTED THAT A CORFLO NASOGASTRIC (NG) FEEDING TUBE WITH STYLET BECAME CLOGGED DURING USE, RESULTING IN INABILITY TO FLUSH FLUID THROUGH THE TUBE (¿PLUG THE PIPE AND NO WATER¿). THE CUSTOMER INDICATED THE DEVICE WAS IN USE AT THE TIME THE ISSUE WAS IDENTIFIED AND REPORTED THAT THE TUBE WAS REPLACED (¿CHANGE NEW¿).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    529618 CORFLO NASOGASTRIC / NASOINTESTINAL FEEDING TUBE DH CPK NG TUBES KNT AVANOS MEDICAL INC. 20-9432 30133122 00350770457991

    Patients

    Seq Age Sex Outcome Treatment
    1