BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MIC GASTROSTOMY FEEDING TUBE WITH ENFIT CONNECTORS-18 FR

    MDR report key: 22544137 · Received July 18, 2025

    Report

    Report Number
    9611594-2025-00161
    Event Type
    Malfunction
    Date Received
    July 18, 2025
    Date of Event
    February 24, 2025
    Report Date
    July 18, 2025
    Manufacturer
    AVANOS MEDICAL INC.
    Product Code
    KNT
    UDI-DI
    00350770442938
    PMA / PMN Number
    K842076
    Product Problem
    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 IS NOT POSSIBLE AS NO LOT NUMBER WAS PROVIDED; THEREFORE, THE UDI-PI IS UNAVAILABLE. THE LOT NUMBER WAS NOT PROVIDED BY THE CUSTOMER. ALL INFORMATION REASONABLY KNOWN AS OF 18-JUL-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 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 MW5168197 THE FOLLOWING INFORMATION: ON (B)(6) 2025, THIS PATIENT HAD A GASTROSTOMY TUBE PLACED IN THE OPERATING ROOM WITH ORDERS FOR GTUBE TO GRAVITY DRAINAGE. IN SETTING UP THE TUBE TO GRAVITY DRAINAGE, THE NURSE SELECTED THE INCORRECT BAG. THE BAG THAT WAS USED WAS A NEPHROSTOMY BAG PRODUCT URESIL REF TC600.THIS BAG WAS INCORRECTLY ATTACHED TO THE GTUBE BALLOON PORT AND RESULTED IN THE DEFLATION OF THE BALLOON AND RESULTED IN THE DISLODGEMENT OF THE TUBE. ON (B)(6)2025, THE PATIENT RETURNED TO THE OPERATING ROOM TO HAVE THE GTUBE REPLACED. ALTHOUGH THERE IS NO DEVICE ERROR, THAT CONTRIBUTED TO HARM, IT WAS NOTED IN THE REVIEW OF THE EVENT THAT THERE IS NO VISUAL INDICATOR OR COLOR CODING FOR THE FEEDING PORTS OR THE BALLOON PORTS. REPORTING TO MAKE THE RECOMMENDATION FOR VISUAL INDICATOR TO DIFFERENTIATE THESE PORTS. MIC GASTROSTOMY FEEDING TUBE WITH ENFIT CONNECTORS 18 F REF 8100-18.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1419838 MIC GASTROSTOMY FEEDING TUBE WITH ENFIT CONNECTORS-18 FR DH EF BALLOON TUBES PRODUCTS KNT AVANOS MEDICAL INC. 8100-18 UNKNOWN 00350770442938

    Patients

    Seq Age Sex Outcome Treatment
    1 1 MO Female