BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CARDINAL HEALTH

    MDR report key: 23816497 · Received December 16, 2025

    Report

    Report Number
    1423537-2025-00505
    Event Type
    Injury
    Date Received
    December 16, 2025
    Date of Event
    December 4, 2025
    Report Date
    February 2, 2026
    Manufacturer
    CARDINAL HEALTH 200, LLC
    Product Code
    KNT
    UDI-DI
    10192253011739
    PMA / PMN Number
    K833621
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE HISTORY RECORD (DHR) COULD NOT BE REVIEWED AS NO LOT INFORMATION 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. A DEVICE WAS NOT RETURNED FOR EVALUATION; THEREFORE, THE AFFECTED PRODUCT COULD NOT BE EVALUATED TO CONFIRM THE REPORTED FAILURE MODE. AS PART OF THE INVESTIGATION ALL PROCESSES AND CONTROLS WERE REVIEWED AND FOUND TO BE CORRECTLY FOLLOWED. THERE WERE NO ABNORMAL CONDITIONS FOUND THAT COULD TRIGGER THE REPORTED CONDITION. BASED ON ALL AVAILABLE INFORMATION, A ROOT CAUSE COULD NOT BE DETERMINED AT THIS TIME. 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.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED THE NGT WAS INSERTED IN IVR ON (B)(6) AND WAS REMOVED TODAY TO FIND A RUPTURED LOOKING TUBE WITH THE DISTAL WEIGHTED PORTION MISSING. THEY ARE WAITING ON A PLAN FOR THE PATIENT TO DETERMINE WHETHER THE PATIENT WILL HAVE A SCOPE OR WAIT AND PASS. POSSIBLE LOT NUMBER: 2519801064. PER ADDITIONAL INFORMATION PROVIDED ON DECEMBER 15TH, 2025, GASTROENTEROLOGY PERFORMED AN ESOPHAGOGASTRODUODENOSCOPY ON (B)(6) BUT THE NG TIP HAD MIGRATED BEYOND REACH. SERIAL X-RAYS AND STOOL CHARTING WERE COMPLETED TO MONITOR THE PROGRESSION OF THE NG TIP. THE FOREIGN BODY WAS REMOVED VIA COLONOSCOPY ON (B)(6) WITHOUT COMPLICATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2444641 CARDINAL HEALTH TUBES, GASTROINTESTINAL (AND ACCESSORIES) KNT CARDINAL HEALTH 200, LLC 8884721055E 10192253011739

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention