BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENFIT PU FEEDING TUBE PURPLE 6.5FR 60CM

    MDR report key: 24758481 · Received April 1, 2026

    Report

    Report Number
    3011270181-2026-00046
    Event Type
    Malfunction
    Date Received
    April 1, 2026
    Date of Event
    February 23, 2026
    Report Date
    April 1, 2026
    Manufacturer
    AVANOS MEDICAL INC.
    Product Code
    FPD
    UDI-DI
    00350770001791
    PMA / PMN Number
    K082238
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE ACTUAL COMPLAINT PRODUCT WAS NOT RETURNED FOR EVALUATION. A REVIEW OF THE DEVICE HISTORY RECORD AND UDI NUMBER ARE IN-PROGRESS. ALL INFORMATION REASONABLY KNOWN AS OF 01-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 21 CFR 803, 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 "A PATIENT WITH AN ENFIT 6.5 FR OROGASTRIC FEEDING TUBE INSERTED ON (B)(6) 2026, WAS RECEIVING MEDICATION ENTERALLY. DURING THE SLOW ADMINISTRATION OF PYRIDOXINE 50 MG TABLETS DILUTED IN 1 CC OF BOILED WATER, AS PER PROTOCOL, THE TUBE WAS FOUND TO BE NON-PATENT. PRESSURE WAS APPLIED TO OVERCOME THE OBSTRUCTION. THE MEDICATION ADVANCED SLOWLY AND WITH DIFFICULTY. WHEN AN ATTEMPT WAS MADE TO FLUSH THE TUBE WITH BOILED WATER, THE WATER FLOWED VERY QUICKLY. THEREFORE, IT WAS DECIDED TO REMOVE THE TUBE USING A CLEAN TECHNIQUE TO CHECK ITS INTEGRITY. HOWEVER, A RUPTURE WAS FOUND AT THE 8.5 FR MARK." THE TUBE WAS IN USE FOR 4-DAYS. THERE WAS NO REPORTED INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    817271 ENFIT PU FEEDING TUBE PURPLE 6.5FR 60CM DH NASOGASTRIC (NG) FEEDING TUBES (NEOMED AND NEOCONNECT) FPD AVANOS MEDICAL INC. PFTM6.5P-NC TY230404 00350770001791

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown