BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PORT-A-CATH IMPLANTABLE ACCESS SYSTEM

    MDR report key: 23534308 · Received November 12, 2025

    Report

    Report Number
    3012307300-2025-12400
    Event Type
    Injury
    Date Received
    November 12, 2025
    Date of Event
    September 25, 2025
    Report Date
    November 12, 2025
    Manufacturer
    ICU MEDICAL HEALTHCARE MANUFACTURING S.A. DE C.V.
    Product Code
    LIT
    UDI-DI
    10610586032776
    PMA / PMN Number
    K072657
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    H3: INVESTIGATION INCLUDING ROOT CAUSE ANALYSIS IS IN PROGRESS. A SUPPLEMENTAL MDR WILL BE FILED AS NECESSARY IN ACCORDANCE WITH 21 CFR 803.56 WHEN ADDITIONAL REPORTABLE INFORMATION BECOMES AVAILABLE.

    Description of Event or Problem · 0

    A LAWSUIT WAS RECEIVED REGARDING PORT-A-CATH IMPLANTABLE ACCESS SYSTEM WITH LIST NUMBER 21-4483-24 AND LOT NUMBER 4163578 CONTAINING THE FOLLOWING ALLEGATIONS. ON (B)(6) 2021 THE PATIENT UNDERWENT PLACEMENT OF THE DEVICE FOR THE PURPOSE OF ONGOING TREATMENT FOR ADMINISTERING CHEMOTHERAPY. ON OR ABOUT (B)(6) 2023, PATIENT DEVELOPED A BLOOD CLOT ALONG WITH SEVERE PAIN AND PERSISTENT PAIN AROUND THE POWERPAC. PATIENT WAS TREATED FOR THE BLOOD CLOT WITH BLOOD THINNERS AND ON OR AROUND (B)(6) 2023 THE PORT WAS REMOVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1951074 PORT-A-CATH IMPLANTABLE ACCESS SYSTEM PORT AND CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR LIT ICU MEDICAL HEALTHCARE MANUFACTURING S.A. DE C.V. 4163578 10610586032776

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female Required Intervention