BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARDINAL HEALTH

    MDR report key: 24501561 · Received March 3, 2026

    Report

    Report Number
    1423537-2026-00053
    Event Type
    Malfunction
    Date Received
    March 3, 2026
    Report Date
    March 5, 2026
    Manufacturer
    CARDINAL HEALTH 200, LLC
    Product Code
    GBX
    UDI-DI
    10192253022391
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    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

    A NON-CONFORMANCE REVIEW WAS CONDUCTED FOR LOT 1241035 AND THERE WERE NO NON-CONFORMANCES RELATED TO THE REPORTED EVENT ISSUED DURING THE MANUFACTURING OF THIS LOT. VISUAL INSPECTION AND PULL TEST WERE CONDUCTED ON THE DRAINS WITHIN THIS LOT AND MET THE ESTABLISHED ACCEPTANCE CRITERIA. THERE WAS NO DEVICE RETURNED FOR EVALUATION; THEREFORE, THE AFFECTED DEVICE COULD NOT BE EVALUATED TO DETERMINE THE ROOT CAUSE. A CORRECTIVE AND PREVENTIVE ACTION HAS BEEN INITIATED TO FURTHER INVESTIGATE THE REPORTED ISSUE. WE WILL CONTINUE TO MONITOR AND TAKE ACTIONS, AS APPLICABLE.

    Description of Event or Problem · 0

    CUSTOMER REPORTED A SILICONE ROUND DRAIN, JACKSON-PRATT, 7FR, BROKE INTO TWO PIECES POST OPERATIVELY. THE EXISTING DRAIN WAS STILL USED AND REMAINING TUBING WAS RECONNECTED TO THE BULB. THERE WAS NO HARM TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    563550 CARDINAL HEALTH CATHETER, IRRIGATION GBX CARDINAL HEALTH 200, LLC SU130-1320 1241035 10192253022391

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention