BEUDAMED
    FDA Adverse Event Death Summary report: N

    INTRODUCER KIT FOR GASTROSTOMY FEEDING TUBE

    MDR report key: 22462626 · Received July 9, 2025

    Report

    Report Number
    9611594-2025-00145
    Event Type
    Death
    Date Received
    July 9, 2025
    Date of Event
    March 27, 2025
    Report Date
    July 9, 2025
    Manufacturer
    AVANOS MEDICAL INC.
    Product Code
    KGC
    PMA / PMN Number
    K080253
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    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; THEREFORE, THE UDI-PI IS UNAVAILABLE. ALL INFORMATION REASONABLY KNOWN AS OF 09 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 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 ON (B)(6) 2025, A PATIENT DIED SHORTLY AFTER GASTRONOMY. THE FACILITY BELIEVE IT IS UNLIKELY THAT AN ISSUE WITH THE KIT CONTRIBUTED TO THE SUTURES FAILING. PER ADDITIONAL INFORMATION RECEIVED ON REPORTABLE ALERT DATE (B)(6) 2025, "PATIENT UNDERWENT ELECTIVE INSERTION OF 14F MICKEY BUTTON USING THE INTRODUCER KIT ON (B)(6). COMMENCED ON ROUTINE FEEDS POST-OPERATIVELY AND DISCHARGED HOME 48 HOURS LATER. REPRESENTED TO LOCAL HOSPITAL AFTER 4 DAYS WITH SUSPECTED PNEUMONIA. UNDERWENT CHANGE IN WATER IN THE BALLOON ON (B)(6) (WAS RECOMMENDED TO NOT PERFORM BEFORE (B)(6)) - UNSURE IF ANY CHECKS TOOK PLACE LOCALLY TO CONFIRM POSITION OF BALLOON - RECOMMENCED ON FEEDS AND DETERIORATED CLINICALLY - CT SCAN SUSPICIOUS OF BALLOON INFLATION OUTSIDE THE STOMACH - LAPAROTOMY ON (B)(6) - CONFIRMED BALLOON OUTSIDE STOMACH - T-FASTENERS CAME AWAY EASILY FROM ABDOMINAL WALL WHEN DRESSING WAS REMOVED AT TIME OF LAPAROTOMY. AT LAPAROTOMY, DEFECT IN STOMACH CLOSED AND FREKA GASTROSTOMY SITED. PATIENT REMAINED IN PICU/HDU ENVIRONMENT FOR 6-7 WEEKS POST-PROCEDURE. DEVELOPED AN ASPIRATION PNEUMONITIS FOLLOWING A FOLLOW-THROUGH STUDY TO ASSESS FOR AN OBSTRUCTION - SUBSEQUENTLY DEMISED 24 HOURS LATER ON (B)(6) 2025. INCIDENT REVIEW MEETING COMPLETED AT (B)(6) WITH LOCAL HOSPITAL." ENDOSCOPY WAS USED AT THE TIME OF INITIAL SURGERY TO VERIFY TUBE PLACEMENT. THE BALLOON INFLATION VOLUME WAS 5ML.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    543957 INTRODUCER KIT FOR GASTROSTOMY FEEDING TUBE DH EF PERC PLACEMENT PRODUCTS KGC AVANOS MEDICAL INC. 98431 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 5 YR Female Death