BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    XCELA

    MDR report key: 22834369 · Received August 18, 2025

    Report

    Report Number
    3008737795-2025-00018
    Event Type
    Malfunction
    Date Received
    August 18, 2025
    Date of Event
    October 28, 2021
    Report Date
    August 18, 2025
    Manufacturer
    PFM MEDICAL CPP SA
    Product Code
    LJT
    PMA / PMN Number
    K073210
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE MANUFACTURER CONDUCTED A DOCUMENTARY REVIEW: PRODUCT MET SPECIFICATIONS PER DOCUMENTARY REVIEW. 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) 2021, PATIENT'S PORT WAS REMOVED BY DR. (B)(6), , MD AT (B)(6), OHIO DUE TO SUSPICION OF INFECTION AFTER POSITIVE BLOOD CULTURES WERE DRAWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1590264 XCELA PORT LJT PFM MEDICAL CPP SA N/A 134753000

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention