BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    KANGAROO

    MDR report key: 21919060 · Received April 28, 2025

    Report

    Report Number
    1423537-2025-00183
    Event Type
    Malfunction
    Date Received
    April 28, 2025
    Date of Event
    April 20, 2025
    Report Date
    August 18, 2025
    Manufacturer
    CARDINAL HEALTH 200, LLC
    Product Code
    KNT
    UDI-DI
    10192253011562
    PMA / PMN Number
    K180622
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL 510K NUMBER: K932295. ADDITIONAL PRODUCT CODE: PIF. AN INVESTIGATION IS CURRENTLY UNDERWAY. UPON COMPLETION THE RESULTS WILL BE FORWARDED.

    Additional Manufacturer Narrative · 0

    A NON-CONFORMANCE REVIEW WAS CONDUCTED FOR THE REPORTED LOT (2400121964) AND THERE WERE NO NCS RELATED TO THE REPORTED EVENT ISSUED DURING THE MANUFACTURING OF THIS LOT. PRIOR TO A LOT¿S RELEASE, THE LOT MUST BE DEEMED ACCEPTABLE BY-PASSING INSPECTIONS THAT ARE BASED ON A VALID SAMPLING PLAN. DURING PRODUCTION, INSPECTORS ROUTINELY EXAMINE A STATISTICAL SAMPLE BOTH PHYSICALLY AND VISUALLY. A DEVICE WAS NOT RETURNED FOR EVALUATION; THEREFORE, THE AFFECTED PRODUCT COULD NOT BE EVALUATED TO CONFIRM THE REPORTED FAILURE MODE. AS SUCH, A ROOT CAUSE COULD NOT BE DETERMINED. WE WILL CONTINUE TO MONITOR RELATED REPORTS TO DETERMINE IF ADDITIONAL ACTIONS ARE NECESSARY.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED THE PATIENT LOST HER KANGAROO 24 FR GTT (GASTROSTOMY FEEDING TUBE), WHICH WAS INFLATED WITH 8 ML OF AD (DISTILLED WATER) ON (B)(6) 2025, DUE TO A RUPTURE OF THE CUFF. SINCE THIS IS A PATIENT DIAGNOSED WITH ALZHEIMER'S, DM, RECURRENT UTIS AND IS BEDRIDDEN, SHE IS UNDER HOME CARE WITH 12 HOURS OF DAYTIME NURSING AND AT NIGHT WITH THE CAREGIVER. SHE HAS LIMITED MOVEMENT, FOR THIS REASON SHE DOES NOT PULL THE GTT. THE TECHNICIANS AND CAREGIVERS ARE COMPLETELY CAUTIOUS, CAPABLE AND EXPERIENCED IN HANDLING, ADMINISTERING MEDICATIONS, DIET AND LIQUIDS THROUGH THIS DEVICE. THE CUFF RUPTURED ON (B)(6) 2025 AND HAD TO BE CHANGED BY A PROFESSIONAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1756802 KANGAROO TUBES, GASTROINTESTINAL (AND ACCESSORIES) KNT CARDINAL HEALTH 200, LLC 8884720247 2400121964 10192253011562

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female