BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENFIT PU FEEDING TUBE ORANGE 5FR 90CM

    MDR report key: 24777229 · Received April 3, 2026

    Report

    Report Number
    3011270181-2026-00047
    Event Type
    Injury
    Date Received
    April 3, 2026
    Date of Event
    March 3, 2026
    Report Date
    April 2, 2026
    Manufacturer
    AVANOS MEDICAL INC.
    Product Code
    FPD
    UDI-DI
    00350770000657
    PMA / PMN Number
    K082238
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NM, 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 IS IN-PROGRESS. ALL INFORMATION REASONABLY KNOWN AS OF 02-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 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 RECEIVED A SINGLE REPORT THAT REFERENCED TWO DIFFERENT INCIDENCES, WHICH WERE ASSOCIATED WITH SEPARATE UNITS, INVOLVING TWO DIFFERENT EVENTS. THIS IS THE FIRST OF TWO REPORTS. REFER TO 3011270181-2026-00048 FOR THE SECOND EVENT. IT WAS REPORTED THERE WAS A PERFORATION OF THE NEO MED FEEDING TUBE IN THE PATIENT. THE ORAL GASTRIC (OG) TUBE AND WAS PLACED AND IMMEDIATELY IT DECOMPENSATED, SHOWED AIR-LEAK IN CHEST CAVITY. ADDITIONAL INFORMATION RECEIVED 11-MAR-2026 THE PATIENT WAS REPORTED TO BE STABLE ON THE VENTILATOR WITH AN UMBILICAL ARTERY (UA) AND AN UMBILICAL VEIN LINE (UV) LINE., THE PATIENT WAS USING THE TUBE FOR INTERMITTENT FEEDINGS. NO ORAL OR CRUSHED MEDICATIONS WERE USED IN THE DEVICE. THE INCIDENT OCCURRED ON INSERTION WHEN THE TUBE WAS BEING FLUSHED. THE DEVICE WAS FLUSHED MANUALLY WITH A SYRINGE. DEVICE PLACEMENT WAS VERIFIED AIR AUSCULTATION. IMAGING WAS OBTAINED AFTER PLACEMENT. A PNEUMOTHORAX OCCURRED AFTER DECOMPENSATION AFTER INSERTION AND THE SPECIFIC FINDINGS PNEUMOTHORAX. THE PNEUMOTHORAX WAS TREATED BY NEEDLE ASPIRATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    837156 ENFIT PU FEEDING TUBE ORANGE 5FR 90CM DH NASOGASTRIC (NG) FEEDING TUBES (NEOMED AND NEOCONNECT) FPD AVANOS MEDICAL INC. FTL5.0P-NC TY250411 00350770000657

    Patients

    Seq Age Sex Outcome Treatment
    1 0 DA Male Other