BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    KANGAROO

    MDR report key: 22151135 · Received June 5, 2025

    Report

    Report Number
    1423537-2025-00224
    Event Type
    Malfunction
    Date Received
    June 5, 2025
    Date of Event
    January 31, 2025
    Report Date
    July 1, 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

    THE DEVICE HISTORY RECORD (DHR) FOR LOT NUMBER 2333917364 WAS REVIEWED AND NO ANOMALIES RELATED TO THE REPORTED ISSUE WERE OBSERVED. THERE WERE NO SAMPLES RETURNED FOR EVALUATION; THEREFORE, THE AFFECTED DEVICE COULD NOT BE EVALUATED TO CONFIRM THE REPORTED FAILURE MODE.AS SUCH, A ROOT CAUSE COULD NOT BE DETERMINED. HOWEVER, THE REPORTED AFFECTED COMPONENT IS PRODUCED BY AN EXTERNAL SUPPLIER; OUR ASSEMBLY PROCESS CONSISTS ONLY OF A PICK AND PLACE OPERATION FOR THIS MATERIAL. A SUPPLIER CORRECTIVE ACTION REQUEST HAS BEEN SENT TO THE SUPPLIER TO FURTHER INVESTIGATE AND ADDRESS THE REPORTED CONDITION. ALL INFORMATION RECEIVED WILL BE USED FOR TRACKING AND TRENDING PURPOSES.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED THAT A RUPTURE OF THE GTT BALLOON WAS OBSERVED AT HOME. THERE WAS NO PATIENT HARM REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    886022 KANGAROO TUBES, GASTROINTESTINAL (AND ACCESSORIES) KNT CARDINAL HEALTH 200, LLC 8884720247 2333917364 10192253011562

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown