BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MIC-KEY GASTROSTOMY FEED TUBE, ENFIT CONNECTORS-14 FR, 2CM

    MDR report key: 24500859 · Received March 3, 2026

    Report

    Report Number
    9611594-2026-00107
    Event Type
    Malfunction
    Date Received
    March 3, 2026
    Date of Event
    January 29, 2026
    Report Date
    March 3, 2026
    Manufacturer
    AVANOS MEDICAL INC.
    Product Code
    KNT
    UDI-DI
    00350770427317
    PMA / PMN Number
    K043114
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    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 03-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 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 THE G-TUBE INSERTED ON (B)(6) 2026. ON (B)(6) 2026, DRESSING CHANGE DUE FOR G-TUBE. DURING A DRESSING CHANGE THE G-TUBE WAS FOUND TO BE DISLODGED. THE NURSE (NP) WAS CONTACTED WHICH IS WHEN THEY INSERTED A FOLEY TEMPORARILY. AT THE TIME OF THE REPORT THE USER INSTILLED STERILE WATER INTO G-TUBE BALLOON PORT AND NOTED IT TO BE LEAKING ONTO BLUE PAD. THE NP WAS ABLE TO FIND A NEW G-TUBE AND A NEW G-TUBE WAS INSERTED WITH CAREGIVER'S CONSENT. THE PATIENT WAS SENT FOR A GASTROINTESTINAL (GI) STUDY TO CONFIRM PLACEMENT WITH CONTRAST. ONCE CONFIRMED BY RADIOLOGY THE PATIENT'S FEEDS WERE RE-STARED THROUGH NEW G-TUBE. NO PATIENT INJURY. PATIENT HAD TO HAVE A REPLACEMENT G-TUBE URGENTLY INSERTED DUE TO IMMATURE TRACT. THERE WAS NO REPORTED INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    554081 MIC-KEY GASTROSTOMY FEED TUBE, ENFIT CONNECTORS-14 FR, 2CM DH EF BALLOON TUBES PRODUCTS KNT AVANOS MEDICAL INC. 8140-14-2.0 30361279 00350770427317

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown