BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MIC PERCUTANEOUS ENDOSCOPIC GASTROSTOMY PEG KIT

    MDR report key: 25059077 · Received May 1, 2026

    Report

    Report Number
    3006646024-2026-00030
    Event Type
    Malfunction
    Date Received
    May 1, 2026
    Date of Event
    March 2, 2026
    Report Date
    May 1, 2026
    Manufacturer
    AVANOS MEDICAL INC.
    Product Code
    KNT
    UDI-DI
    00350770958163
    PMA / PMN Number
    K924065
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    EI
    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. A ROOT CAUSE HAS NOT BEEN ESTABLISHED. ALL INFORMATION REASONABLY KNOWN AS OF 30 APR 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).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A PATIENT HAD A PEG TUBE WITH BUMPER INSERTED 3 YEARS AGO. BACK THEN, THE PATIENT WAS DISCHARGED TO A NURSING HOME FOR LONG TERM CARE. HOWEVER, THE NURSING HOME WERE NOT AWARE THAT CORFLO PEG FIXATOR HAD TO BE OPENED, TUBE ADVANCED AND ROTATED WEEKLY TO PREVENT BURIED BUMPER SYNDROME. ON (B)(6) 2026 NURSING HOME STAFF WERE UNABLE TO FLUSH PEG. THE PATIENT WAS SENT TO THE HOSPITAL, AND THEY DISCOVERED THAT THE PATIENT HAD BURIED BUMPER SYNDROME. THE PATIENT UNDERWENT A SURGICAL PROCEDURE TO REMOVE BURIED BUMPER AND HAVE NEW STOMA SITE FORMED FOR NEW PEG. FORMAL TRAINING GIVEN TO NURSING HOME BY HOSPITAL DIETICIAN TO PREVENT ANY REOCCURRENCE OF BURIED BUMPER SYNDROME. THE PATIENT'S CONDITION IS STABLE, DISCHARGED FROM HOSPITAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    385293 MIC PERCUTANEOUS ENDOSCOPIC GASTROSTOMY PEG KIT DH EF PEG INITIAL PLACEMENT PRODUCTS KNT AVANOS MEDICAL INC. 0630-20 UNKNOWN 00350770958163

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Male