BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENFIT PU FEEDING TUBE ORANGE

    MDR report key: 25161712 · Received May 13, 2026

    Report

    Report Number
    3011270181-2026-00069
    Event Type
    Malfunction
    Date Received
    May 13, 2026
    Date of Event
    December 26, 2023
    Report Date
    May 13, 2026
    Manufacturer
    AVANOS MEDICAL INC.
    Product Code
    FPD
    UDI-DI
    00350770000657
    PMA / PMN Number
    K082238
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    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 ACTUAL COMPLAINT PRODUCT WAS NOT RETURNED FOR EVALUATION. A REVIEW OF THE DEVICE HISTORY RECORD IS NOT POSSIBLE AS NO LOT NUMBER WAS PROVIDED; THEREFORE, THE UDI-PI IS UNAVAILABLE. A ROOT CAUSE HAS NOT BEEN ESTABLISHED. ALL INFORMATION REASONABLY KNOWN AS OF 13 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 A FEEDING TUBE BROKE WHILE IN THE PATIENT. IT HAD BEEN IN PLACE FOR FOUR DAYS. WHILE CLEANING THE END WITH THE PURPLE CLEANING TOOL, THE FEEDING TUBE BROKE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    75895 ENFIT PU FEEDING TUBE ORANGE DH NASOGASTRIC (NG) FEEDING TUBES (NEOMED AND NEOCONNECT) FPD AVANOS MEDICAL INC. FTL5.0P-NC UNKNOWN 00350770000657

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown