BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CARDINAL HEALTH

    MDR report key: 23586264 · Received November 18, 2025

    Report

    Report Number
    1423537-2025-00463
    Event Type
    Injury
    Date Received
    November 18, 2025
    Date of Event
    September 4, 2025
    Report Date
    December 19, 2025
    Manufacturer
    CARDINAL HEALTH 200, LLC
    Product Code
    KNT
    UDI-DI
    10192253011296
    PMA / PMN Number
    K112511
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE HISTORY RECORD WAS REVIEWED AND INDICATED THAT THE PRODUCT WAS RELEASED ACCOMPLISHING ALL QUALITY STANDARDS. 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. 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 GUIDEWIRE OF A FEEDING TUBE WAS NOT REMOVED AFTER INSERTION. THE PORT AND THE GUIDEWIRE LOOK ALIKE AND ARE THE SAME COLOR MAKING DIFFERENTIATION DIFFICULT FOR AN INEXPERIENCED CLINICIAN TO DETERMINE THE DIFFERENCE. PER ADDITIONAL INFORMATION RECEIVED ON NOVEMBER 05, 2025, THERE WAS NO SPECIFIC INJURY THAT RESULTED TO THE PATIENT BUT THIS EVENT MET THEIR REPORTABILITY REQUIREMENT UNDER UNINTENTIONAL RETAINED FOREIGN ITEM. WHEN THEY REFER TO A RETAINED FOREIGN ITEM, THEY ARE REFERRING TO THE STYLET THAT WAS LEFT INSIDE THE NG TUBE THAT WAS INSERTED INTO THE PATIENT ONLY. THE ENTERAL FEEDING TUBE WAS REMOVED ENTIRELY BUT NOT REPLACED AS THE FAMILY FINALLY AGREED ON PEG TUBE INSERTION WHICH WAS DONE 3 DAYS AFTER THE RETAINED FOREIGN ITEM DISCOVERY. THE PATIENT WAS SENT BACK TO THE ED BECAUSE OF THE TUBE FEEDING MALFUNCTION ON (B)(6) 2025, THE PEG TUBE WAS INSERTED ON (B)(6) 2025, AND THEY WERE DISCHARGED (B)(6) 2025. PER FURTHER INFORMATION PROVIDED ON (B)(6) 2025, THE PATIENT PRESENTED TO (B)(6) ON (B)(6) 2025 FROM THE (B)(6) DUE TO THE FEEDING TUBE BEING PULLED OUT BY PATIENT AND WAS REPLACED. HE WAS DISCHARGED BACK ON (B)(6) 2025 TO (B)(6). THE PATIENT WAS READMITTED ON (B)(6) 2025 DUE TO TUBE FEEDING MALFUNCTION AND IT WAS DISCOVERED THAT THE GUIDEWIRE WAS STILL PRESENT AFTER 4 DAYS OF USE IN THE (B)(6). THE GUIDEWIRE WAS LEFT IN FOR 4 DAYS, THEN IT WAS NOT USABLE ANYMORE HENCE HIM BEING SENT BACK TO THE ED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1493942 CARDINAL HEALTH TUBES, GASTROINTESTINAL (AND ACCESSORIES) KNT CARDINAL HEALTH 200, LLC 8884711253E 2518800164 10192253011296

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Male Hospitalization