BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CARDINAL HEALTH JACKSON PRATT

    MDR report key: 24654783 · Received March 20, 2026

    Report

    Report Number
    1423537-2026-00078
    Event Type
    Injury
    Date Received
    March 20, 2026
    Date of Event
    February 17, 2026
    Report Date
    April 7, 2026
    Manufacturer
    CARDINAL HEALTH 200, LLC
    Product Code
    GBX
    UDI-DI
    10192253022247
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    NURSE
    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 1240157 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

    ON (B)(6) 2025, THE PATIENT HAD AN INITIAL SURGERY FOR L5-S1 TLIF. CUSTOMER REPORTED THE DRAIN BROKE OFF AND WAS RETAINED INSIDE THE PATIENT. ON (B)(6) 2025, THE PATIENT WAS BROUGHT BACK TO SURGERY FOR I&D OF LUMBAR WOUND. THE SURGEON DID NOT STATE THAT HE REMOVED ANY RETAINED DRAIN PIECES AND IT IS NOT DOCUMENTED IN THE SPECIMEN PORTION OF THE INTRAOPERATIVE RECORD. NO FURTHER INFORMATION WAS PROVIDED BY THE CUSTOMER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    328149 CARDINAL HEALTH JACKSON PRATT CATHETER, IRRIGATION GBX CARDINAL HEALTH 200, LLC SU130-0323 1240157 10192253022247

    Patients

    Seq Age Sex Outcome Treatment
    1