BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NEOMED NASOGASTRIC/OROGASTRIC FEEDING TUBES

    MDR report key: 24273030 · Received February 5, 2026

    Report

    Report Number
    3011270181-2026-00018
    Event Type
    Malfunction
    Date Received
    February 5, 2026
    Date of Event
    April 20, 2025
    Report Date
    February 5, 2026
    Manufacturer
    AVANOS MEDICAL INC.
    Product Code
    FPD
    UDI-DI
    00350770002347
    PMA / PMN Number
    K082238
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    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 PRODUCT INVOLVED IN THE REPORT HAS BEEN RETURNED AND THE INVESTIGATION REMAINS IN PROGRESS AT THIS TIME. A REVIEW OF THE DEVICE HISTORY RECORD AND UDI ARE IN-PROGRESS. ALL INFORMATION REASONABLY KNOWN AS OF 05 FEB 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 FOUR DIFFERENT INCIDENCES, WHICH WERE ASSOCIATED WITH SEPARATE UNITS, INVOLVING DIFFERENT PATIENTS. THIS IS THE FOURTH OF FOUR REPORTS. REFER TO 3011270181-2026-00015 FOR THE FIRST REPORT REFER TO 3011270181-2026-00016 FOR THE SECOND REPORT . REFER TO 3011270181-2026-00017 FOR THE THIRD REPORT. IT WAS REPORTED, FEEDING TUBE IS BLOCKED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    331189 NEOMED NASOGASTRIC/OROGASTRIC FEEDING TUBES DH NASOGASTRIC (NG) FEEDING TUBES (NEOMED AND NEOCONNECT) FPD AVANOS MEDICAL INC. PFTM6.5P-EO TY220916 00350770002347

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown