BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NEOMED NASOGASTRIC/OROGASTRIC FEEDING TUBES

    MDR report key: 24621352 · Received March 17, 2026

    Report

    Report Number
    3011270181-2026-00038
    Event Type
    Malfunction
    Date Received
    March 17, 2026
    Report Date
    March 17, 2026
    Manufacturer
    AVANOS MEDICAL INC.
    Product Code
    FPD
    UDI-DI
    00350770001784
    PMA / PMN Number
    K082238
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    NURSE
    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 NOT POSSIBLE AS NO LOT NUMBER WAS PROVIDED; THEREFORE, THE UDI-PI IS UNAVAILABLE. A ROOT CAUSE COULD NOT BE DETERMINED. ALL INFORMATION REASONABLY KNOWN AS OF 17 MAR 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 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

    AVANOS MEDICAL INC. RECEIVED A SINGLE REPORT THAT REFERENCED DIFFERENT INCIDENTS, WHICH WERE ASSOCIATED WITH SEPARATE UNITS, INVOLVING DIFFERENT PATIENTS. THIS IS THE THIRD OF THREE REPORTS. REFER TO 3011270181-2026-00036 FOR THE FIRST REPORT, REFER TO 3011270181-2026-00037 FOR THE SECOND REPORT . THE CUSTOMER REPORTED THAT CLINICIANS ON THE INFANT TODDLER FLOOR EXPERIENCED OCCLUSION ALARMS WHEN USING KANGAROO PUMPS WITH AVANOS 6.5 FR NEOMED FEEDING TUBES (REF: PFTS6.5P-NC) DURING INFUSION. THE PUMP ALARMED ¿OCCLUDED¿ AND DID NOT RESPOND TO TROUBLESHOOTING. THE ISSUE OCCURRED DURING USE WITH PEDIALYTE (THIN LIQUID), AND CLINICIANS SUSPECTED A POSSIBLE PSI OR PRESSURE SETTING ISSUE RELATED TO THE FEEDING TUBE. MULTIPLE EVENTS WERE REPORTED WITH THIS TUBE SIZE OVER THE COURSE OF A WEEK. THE EXACT QUANTITY IS UNKNOWN. NO PATIENT INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    683059 NEOMED NASOGASTRIC/OROGASTRIC FEEDING TUBES DH NASOGASTRIC (NG) FEEDING TUBES (NEOMED AND NEOCONNECT) FPD AVANOS MEDICAL INC. PFTS6.5P-NC UNKNOWN 00350770001784

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown KANGAROO PUMPS