BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CARDINAL HEALTH

    MDR report key: 23330889 · Received October 17, 2025

    Report

    Report Number
    1423537-2025-00416
    Event Type
    Injury
    Date Received
    October 17, 2025
    Date of Event
    May 19, 2025
    Report Date
    December 24, 2025
    Manufacturer
    CARDINAL HEALTH 200, LLC
    Product Code
    GBX
    UDI-DI
    10192253022230
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    AN INVESTIGATION IS CURRENTLY IN PROGRESS. A FOLLOW-UP REPORT WILL BE FILED ONCE THE RESULTS HAVE BEEN COMPLETED.

    Additional Manufacturer Narrative · 0

    LOT 1250349 WAS MANUFACTURED ON 04/14/25. VISUAL INSPECTION AND PULL TEST WERE CONDUCTED ON THE DRAINS WITHIN THIS LOT AND AND THE DRAINS PASSED THE ESTABLISHED ACCEPTANCE CRITERIA. A SAMPLE WAS RECEIVED FOR INVESTIGATION. VISUAL AND MICROSCOPIC INSPECTION WAS CONDUCTED AND BREAKAGE IN THE NON-PERFORATED AREA WAS OBSERVED. NO MANUFACTURING ISSUES WERE IDENTIFIED FOR THIS WORK ORDER. THERE WAS NO EVIDENCE OF EXCESSIVE FORCE OR ABNORMAL HANDLING OBSERVED ON THE RETURNED SAMPLE. THE ROOT CAUSE CANNOT BE DETERMINED. WE WILL CONTINUE TO MONITOR RELATED REPORTS TO DETERMINE IF ADDITIONAL ACTIONS ARE NECESSARY.

    Additional Manufacturer Narrative · 0

    CORRECTION REPORT BEING FILED AGAINST MDR 1423537-2025-00416, FOLLOW-UP 1. H1 HAD BEEN INADVERTENTLY MARKED AS MALFUNCTION. H1 HAS BEEN CORRECTED TO A SERIOUS INJURY. NO OTHER CHANGES TO THE REPORT ARE REQUIRED.

    Description of Event or Problem · 0

    CUSTOMER REPORTED THAT ON THE EVENING OF DAY OF SURGERY FOR A REVISION HEMILAMINECTOMY L2-3 RIGHT (BACK), THE PATIENT WAS BLEEDING HEAVILY FROM THE SURGICAL SITE INTO AND AROUND THE JP DRAIN. THEN THE PATIENT SUDDENLY HAD MINIMAL DRAINAGE OUTPUT. DR. ORDERED STRIPPING DRAIN TUBING. WHEN THIS WAS DONE THE TUBING SNAPPED EASILY WITH MINIMAL PRESSURE TO TUBING. THIS THEN REQUIRED A RETURN TO THE OPERATING ROOM. UNDER ANESTHESIA, A HEMATOMA WAS EVACUATED, THE WOUND WAS WASHED OUT, AND TWO NEW SURGICAL DRAINS WERE PLACED. THE PATIENT FULLY RECOVERED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1342266 CARDINAL HEALTH CATHETER, IRRIGATION GBX CARDINAL HEALTH 200, LLC SU130-0321 1250349 10192253022230

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Male Required Intervention| O