BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NEOMED SILICONE FEEDING TUBES (NON ENFIT)

    MDR report key: 15932659 · Received December 7, 2022

    Report

    Report Number
    3011270181-2022-00084
    Event Type
    Malfunction
    Date Received
    December 7, 2022
    Report Date
    December 7, 2022
    Manufacturer
    AVANOS MEDICAL INC.
    Product Code
    FPD
    UDI-DI
    20350770002129
    PMA / PMN Number
    K072881
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    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. ROOT CAUSE COULD NOT BE DETERMINED. ALL INFORMATION REASONABLY KNOWN AS OF 06 DEC 2022 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 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, WHEN THE NEONATE INTENSIVE CARE UNIT (NICU) NURSE REMOVED THE FEEDING TUBE FROM THE BABY THEY NOTED THE TUBE WAS BROKEN OFF. THERE WAS NO REPORTED INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    814206 NEOMED SILICONE FEEDING TUBES (NON ENFIT) DH NASOGASTRIC (NG) FEEDING TUBES (NEOMED AND NEOCONNECT) FPD AVANOS MEDICAL INC. FTM6.5S-EO UNKNOWN 20350770002129

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown