BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENFIT PU FEEDING TUBE PURPLE 6.5FR 60CM

    MDR report key: 25143176 · Received May 11, 2026

    Report

    Report Number
    3011270181-2026-00067
    Event Type
    Malfunction
    Date Received
    May 11, 2026
    Date of Event
    September 15, 2025
    Report Date
    May 11, 2026
    Manufacturer
    AVANOS MEDICAL INC.
    Product Code
    FPD
    PMA / PMN Number
    K082238
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE ACTUAL COMPLAINT PRODUCT WAS NOT RETURNED FOR EVALUATION. A REVIEW OF THE DEVICE HISTORY RECORD FOR THE PROVIDED IS IN-PROGRESS. ALL INFORMATION REASONABLY KNOWN AS OF 11-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 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 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 VIA FDA MEDWATCH / FDA USER FACILITY REPORT MW REPORT MW5176288 THE FOLLOWING: "ON (B)(6) 2025: INFANT HAD A 6.5 FRENCH OROGASTRIC TUBE NEOMED FEEDING TUBE WITH ENFIT CONNECTOR. WHEN ATTEMPTING TO AUSCULTATE IT WAS NOTED THAT AIR AND RESIDUAL FEEDING WAS COMING OUT OF TUBE AT THE 18CM MARK ON TUBE. TUBE WAS REMOVED AND NOTED TO BE SPLIT AT THE 18 CENTIMETERS MARK. TUBE WAS INSERTED ON (B)(6) 2025 AND SECURED AT 16CM. UNKNOWN HOW THE SPLIT OCCURRED."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    538995 ENFIT PU FEEDING TUBE PURPLE 6.5FR 60CM DH NASOGASTRIC (NG) FEEDING TUBES (NEOMED AND NEOCONNECT) FPD AVANOS MEDICAL INC. PFTM6.5P-NC TY250308

    Patients

    Seq Age Sex Outcome Treatment
    1 1 MO Male