BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    KANGAROO

    MDR report key: 21035626 · Received December 30, 2024

    Report

    Report Number
    1423537-2024-00359
    Event Type
    Malfunction
    Date Received
    December 30, 2024
    Date of Event
    October 19, 2024
    Report Date
    January 13, 2025
    Manufacturer
    CARDINAL HEALTH 200, LLC
    Product Code
    KNT
    UDI-DI
    10192253007916
    PMA / PMN Number
    K163002
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE HISTORY RECORD (DHR) COULD NOT BE REVIEWED AS THE SERIAL NUMBER WAS PROVIDED WITHIN THE COMPLAINT. 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. THERE WERE NO SAMPLES RETURNED FOR EVALUATION THEREFORE THE AFFECTED DEVICE COULD NOT BE PHYSICALLY EVALUATED. HOWEVER, PHOTOS WERE PROVIDED. THE PHOTOS WERE INSPECTED, AND THE REPORTED CONDITION WAS CONFIRMED. BASED ON ALL AVAILABLE INFORMATION, A DEFINITIVE ROOT CAUSE COULD NOT BE DETERMINED. HOWEVER, IT IS IMPORTANT TO NOTE THAT BASED ON THE PROVIDED INFORMATION, THE TUBE HAD BEEN IN THE PATIENT FOR MORE THAN 50 DAYS WHICH IS BEYOND THE RECOMMENDED 28 DAYS NOTED IN THE INSTRUCTIONS FOR USE (IFU). WE WILL CONTINUE TO MONITOR RELATED REPORTS TO DETERMINE IF ADDITIONAL ACTIONS ARE NECESSARY.

    Additional Manufacturer Narrative · 0

    AN INVESTIGATION IS CURRENTLY UNDERWAY. UPON COMPLETION, THE RESULTS WILL BE FORWARDED. ADDITIONAL 510K NUMBER K123555.

    Additional Manufacturer Narrative · 0

    THE DEVICE HISTORY RECORD (DHR) COULD NOT BE REVIEWED AS THE SERIAL NUMBER WAS NOT PROVIDED WITHIN THE COMPLAINT.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED WHILE REMOVING THE TUBE FROM THE PATIENT THEY OBSERVED THAT THE TIP HAD PARTIALLY DISINTEGRATED. UPON COMPARING IT WITH A NEW, UNUSED DEVICE, IT WAS CLEAR THAT THE ORIGINAL CONVEX DOME OF THE TIP HAD BEEN "EATEN AWAY." A PORTION OF THE TIP IS MISSING. ADDITIONAL INFORMATION RECEIVED: THE PATIENT HAD NO PROCEDURES TO LOCATE THE MISSING PIECE OF THE TUBE. THE PATIENT DID NOT REQUIRE ANY MEDICATIONS DUE TO THE MISSING PIECE OF THE TUBE. THE TUBE WAS PLACED ON (B)(6) 2024, AND REMOVED ON (B)(6) 2024. NUTRITION USED WAS PIVOT, UP TO 85 ML/HR FOR THE DURATION OF THE TUBE IN PLACE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2227173 KANGAROO TUBES, GASTROINTESTINAL (AND ACCESSORIES) KNT CARDINAL HEALTH 200, LLC 461243E 10192253007916

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown