BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COVIDIEN

    MDR report key: 25072407 · Received May 4, 2026

    Report

    Report Number
    1423537-2026-00143
    Event Type
    Malfunction
    Date Received
    May 4, 2026
    Date of Event
    January 2, 2026
    Report Date
    May 26, 2026
    Manufacturer
    CARDINAL HEALTH, INC.
    Product Code
    KNT
    UDI-DI
    10884521661684
    PMA / PMN Number
    K180622
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL PRODUCT CODE: PIF AN INVESTIGATION IS CURRENTLY UNDERWAY. UPON COMPLETION THE RESULTS WILL BE FORWARDED.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED THE RETENTION DISC WAS LOOSE AND STOMA LEAKAGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    78054 COVIDIEN TUBES, GASTROINTESTINAL (AND ACCESSORIES) KNT CARDINAL HEALTH, INC. 8884720163E 2526101164 10884521661684

    Patients

    Seq Age Sex Outcome Treatment
    1