BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PU FEEDING TUBE ORANGE

    MDR report key: 21691698 · Received March 25, 2025

    Report

    Report Number
    3011270181-2025-00004
    Event Type
    Injury
    Date Received
    March 25, 2025
    Date of Event
    July 15, 2024
    Report Date
    June 9, 2026
    Manufacturer
    AVANOS MEDICAL INC.
    Product Code
    FPD
    UDI-DI
    00350770002224
    PMA / PMN Number
    K082238
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    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 AND UDI ARE IN-PROGRESS. LINK TO MAUDE: HTTPS://WWW.ACCESSDATA.FDA.GOV/SCRIPTS/CDRH/CFDOCS/CFMAUDE/DETAIL.CFM?MDRFOI__ID=20722752&PC=BSS. ALL INFORMATION REASONABLY KNOWN AS OF 24 MAR 2025 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 VIA FDA MAUDE ADVERSE EVENT REPORT MDR REPORT KEY (B)(4), ¿THE AVANOS POLYURETHANE NEONATAL FEEDING TUBES WERE SUSPECTED TO BE ASSOCIATED WITH THREE NEONATAL ESOPHAGEAL PERFORATIONS DURING INSERTION. OROGASTRIC TUBE PLACEMENT ATTEMPTED WITH RESISTANCE MET. ATTEMPTED TO PLACE WITH SMALLER OROGASTRIC TUBE WITH RESISTANCE AGAIN MET.¿

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1803622 PU FEEDING TUBE ORANGE DH NASOGASTRIC (NG) FEEDING TUBES (NEOMED AND NEOCONNECT) FPD AVANOS MEDICAL INC. FTM6.5P-EO TY220305 00350770002224

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other