BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PORT

    MDR report key: 23829971 · Received December 17, 2025

    Report

    Report Number
    3008797795-2025-00040
    Event Type
    Injury
    Date Received
    December 17, 2025
    Date of Event
    April 16, 2025
    Report Date
    December 17, 2025
    Manufacturer
    PFM MEDICAL CPP SA
    Product Code
    LJT
    PMA / PMN Number
    K072481
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE MANUFACTURER CONDUCTED A DOCUMENTARY REVIEW ON THE BATCH PROVIDED: NO DEVIATION WAS FOUND. WITHOUT RETURNED PRODUCT FOR TECHNICAL INVESTIGATION, IT IS NOT POSSIBLE TO CONFIRM THE REPORTED DEFECT. THE RELATED RISKS ARE IDENTIFIED IN OUR RISK MANAGEMENT FILE AND PROCEDURE CLEARLY DESCRIBED IN THE IFU. THEREFORE, COMPLAINT IS CLASSIFIED AS NO DEFINITIVE CONCLUSION, UNVERIFIABLE (NO RETURN PRODUCT).

    Description of Event or Problem · 0

    ON OR ABOUT (B)(6) 2018, PATIENT UNDERWENT PLACEMENT OF AN ANGIODYNAMICS XCELA PLUS PORT IN HER LEFT CHEST WALL, REFERENCE NUMBER H965451270, LOT NUMBER 141602. THE DEVICE WAS IMPLANTED BY (B)(6), DO AT (B)(6) HOSPITAL IN (B)(6), FOR THE PURPOSE OF ONGOING VEIN ACCESS FOR CHEMOTHERAPY TO TREAT THE PATIENT'S BREAST CANCER. ON OR ABOUT (B)(6) 2025, PATIENT WENT TO OUTPATIENT APPOINTMENT WITH HEMATOLOGY/ONCOLOGY WHERE SHE REPORTED THAT SHE DEVELOPED SYMPTOMS OF COUGH AND CONGESTION INITIALLY AND THEN DEVELOPED NAUSEA AND VOMITING OVER THE PRIOR FEW DAYS. BLOODWORK WAS DONE WHICH SHOWED HER POTASSIUM LEVEL WAS SIGNIFICANTLY LOW AND SUGGESTED SEPSIS AND INFECTION. ON OR ABOUT (B)(6) 2025 PATIENT UNDERWENT A PORT REMOVAL PROCEDURE. THE PROCEDURE WAS PERFORMED BY (B)(6), MD AT (B)(6). UPON REMOVAL OF THE PORT, THE CATHETER TIP WAS SENT FOR CULTURE, WHICH RETURNED GROWING GROUP B STREP BACTEREMIA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2040270 PORT XCELA LJT PFM MEDICAL CPP SA 141602000

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention| L