BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CARDINAL HEALTH

    MDR report key: 22977044 · Received September 5, 2025

    Report

    Report Number
    1423537-2025-00356
    Event Type
    Injury
    Date Received
    September 5, 2025
    Date of Event
    August 18, 2025
    Report Date
    September 24, 2025
    Manufacturer
    CARDINAL HEALTH 200, LLC
    Product Code
    KNT
    UDI-DI
    10192253011753
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    AN INVESTIGATION IS CURRENTLY UNDERWAY. UPON COMPLETION, THE RESULTS WILL BE FORWARDED.

    Additional Manufacturer Narrative · 0

    A PHYSICAL SAMPLE WAS NOT RETURNED FOR INVESTIGATION, BUT A PHOTO WAS PROVIDED. THE PHOTO WAS EVALUATED, AND THE REPORTED CONDITION WAS OBSERVED. 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. BASED ON ALL AVAILABLE INFORMATION, THE ROOT CAUSE COULD NOT BE DETERMINED AT THIS TIME. HOWEVER, A CORRECTIVE AND PREVENTATIVE ACTION HAS BEEN OPENED TO ADDRESS THE REPORTED CONDITION. WE WILL CONTINUE TO MONITOR RELATED REPORTS TO DETERMINE IF ADDITIONAL ACTIONS ARE NECESSARY. CORRECTED SECTION H1 TO REFLECT SERIOUS INJURY RATHER THAN MALFUNCTION.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED THAT A CHARGE NURSE INSERTED A DOBBHOFF TUBE INTO A PATIENT ON THE PCU NEURO MEDICAL UNIT. AFTER INSERTION THEY NOTICED BLEEDING FROM THE NARES, SO THEY REMOVED THE DOBBHOFF AND FOUND THE TIP WAS GONE. XRAY PERFORMED AND THE TIP WAS FOUND IN THE STOMACH. PER ADDITIONAL INFORMATION RECEIVED, THE TIP OF THE TUBE NEEDED TO BE REMOVED VIA EGD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    322006 CARDINAL HEALTH TUBES, GASTROINTESTINAL (AND ACCESSORIES) KNT CARDINAL HEALTH 200, LLC 8884721088E 10192253011753

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention