BEUDAMED
    FDA Adverse Event Injury Summary report: N

    XCELA

    MDR report key: 21307667 · Received February 4, 2025

    Report

    Report Number
    3008737795-2024-00024
    Event Type
    Injury
    Date Received
    February 4, 2025
    Date of Event
    January 1, 2025
    Report Date
    February 4, 2025
    Manufacturer
    PFM MEDICAL CPP SA
    Product Code
    LJT
    UDI-DI
    00764014511032
    PMA / PMN Number
    K072481
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MT, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    ITEM NUMBER, ITEM DESCRIPTION, LOT NUMBER, EXPIRATION DATE, UDI: (B)(6), XCELA POWER INJECTABLE PORT WITH 9.6F X 500 MM ATTACHABLE POLYURETHANE CATHETER AND SILICONE PLUGS, 152926000, 2028-02-19, 0764014511032. THE MANUFACTURER CONDUCTED A DOCUMENTARY REVIEW: PRODUCT SOLD TO THIS FACILITY MET THEIR SPECIFICATIONS PER DOCUMENTARY REVIEW. WITHOUT RETURNED PRODUCT FOR TECHNICAL INVESTIGATION, IT IS NOT POSSIBLE TO CONFIRM THE REPORTED DEFECT "RETAINED IN SUBCUTANEOUS TISSUE". THE RELATED RISK IS IDENTIFIED IN OUR RISK MANAGEMENT FILE. THEREFORE, COMPLAINT IS CLASSIFIED AS NO DEFINITIVE CONCLUSION, UNVERIFIABLE (NO RETURN PRODUCT). FOLLOW UP 1- CORRECTION TO SECTION E- INITIAL REPORTER INFORMATION WAS INCORRECT. INITIAL REPORTER ALSO SENT A REPORT TO FDA, CORRECTED TO CHECKING "YES" BOX.

    Additional Manufacturer Narrative · 0

    ITEM NUMBER, ITEM DESCRIPTION, LOT NUMBER, EXPIRATION DATE, UDI: H965451830, XCELA POWER INJECTABLE PORT WITH 9.6F X 500 MM ATTACHABLE POLYURETHANE CATHETER AND SILICONE PLUGS, 152926000, 2028-02-19, (B)(4). THE MANUFACTURER CONDUCTED A DOCUMENTARY REVIEW: PRODUCT SOLD TO THIS FACILITY MET THEIR SPECIFICATIONS PER DOCUMENTARY REVIEW. WITHOUT RETURNED PRODUCT FOR TECHNICAL INVESTIGATION, IT IS NOT POSSIBLE TO CONFIRM THE REPORTED DEFECT "RETAINED IN SUBCUTANEOUS TISSUE". THE RELATED RISK IS IDENTIFIED IN OUR RISK MANAGEMENT FILE. THEREFORE, COMPLAINT IS CLASSIFIED AS NO DEFINITIVE CONCLUSION, UNVERIFIABLE (NO RETURN PRODUCT).

    Description of Event or Problem · 0

    PORT REMOVAL. PATIENT RETURNED TO ED WITH PAIN AT PORT SITE. PORT CATHETER CONNECTOR WAS RETAINED IN THE SUBCUTANEOUS TISSUE.

    Description of Event or Problem · 0

    PORT REMOVAL. PATIENT RETURNED TO ED WITH PAIN AT PORT SITE. PORT CATHETER CONNECTOR WAS RETAINED IN THE SUBCUTANEOUS TISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1060791 XCELA XCELA INJECTABLE PORT LJT PFM MEDICAL CPP SA H965451830 152926 00764014511032

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention