BEUDAMED
    FDA Adverse Event Injury Summary report: N

    10FR SILICONE DRAIN WITH TROCAR

    MDR report key: 22198741 · Received June 12, 2025

    Report

    Report Number
    1423537-2025-00252
    Event Type
    Injury
    Date Received
    June 12, 2025
    Date of Event
    May 19, 2025
    Report Date
    June 27, 2025
    Manufacturer
    CARDINAL HEALTH 200, LLC
    Product Code
    GBX
    UDI-DI
    10192253022230
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    AS NO SAMPLES WERE RETURNED FOR EVALUATION, A ROOT CAUSE COULD NOT BE DETERMINED. A REVIEW OF THE DEVICE HISTORY RECORD FOR THE REPORTED LOT NUMBER 1250068 WAS FOUND TO HAVE BEEN MANUFACTURED AND RELEASED TO PREDETERMINED SPECIFICATIONS. NO ANOMALIES WERE FOUND DURING REVIEW OF THE RECORDS. PULL TESTING WAS CONDUCTED ON THE RETAINED DRAINS WITHIN THIS LOT, AND ALL RESULTS MET THE ESTABLISHED ACCEPTANCE CRITERIA. CARDINAL HEALTH WILL CONTINUE TO MONITOR AND TREND ALL SIMILAR REPORTED PRODUCT RELATED ISSUES.

    Additional Manufacturer Narrative · 0

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

    Description of Event or Problem · 0

    CUSTOMER REPORTED THAT A PATIENT HAD A RETURN TO SURGERY FOR A FRACTURED JP DRAIN. PER MD, "DRAIN TUBING BROKEN WITH RETROGRADE FLOW OF BLOOD AND ANTEROGRADE FLOW OF BLOOD". THIS RESULTED IN RETURN TO THE OR FOR EVACUATION OF HEMATOMA AND REPLACEMENT OF THE DRAIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1362274 10FR SILICONE DRAIN WITH TROCAR CATHETER, IRRIGATION GBX CARDINAL HEALTH 200, LLC SU130-0321 1250068 10192253022230

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Male Required Intervention