BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PORT-A-CATH IMPLANTABLE ACCESS SYSTEM

    MDR report key: 17445968 · Received August 2, 2023

    Report

    Report Number
    3012307300-2023-07746
    Event Type
    Injury
    Date Received
    August 2, 2023
    Date of Event
    September 9, 2019
    Report Date
    August 2, 2023
    Manufacturer
    ST PAUL
    Product Code
    LJT
    UDI-DI
    10610586032776
    PMA / PMN Number
    K072657
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DE, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    NO PRODUCT OR PHOTOS WERE RETURNED THEREFORE NO DEVICE ANALYSIS COULD BE COMPLETED. A DEVICE HISTORY RECORD (DHR) REVIEW REPORTED NO DISCREPANCIES OR NON-CONFORMANCES DURING THE MANUFACTURING OF THE REPORTED LOT NUMBER. IF THE PRODUCT IS RETURNED THE MANUFACTURER WILL RE-OPEN THE COMPLAINT FOR FURTHER DEVICE ANALYSIS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A PATIENT HAD A PORT A CATH PLACED ON (B)(6) 2019. ON (B)(6) 2019, 45 MINUTES INTO POTASSIUM INFUSION AT A MEDICAL FACILITY, THE PATIENT BEGAN COMPLAINING OF BURNING PAIN TO HER NECK AND SWELLING. THE INFUSION WAS STOPPED AND SENT FOR STAT DYE STUDY. IVR CONTRAST EXAM FINDING SHOWED EARLY EXTRAVASATION OF CONTRAST AT THE CEPHALAD MOST PORTION OF THE CATHETER IN THE RIGHT INTERNAL JUGULAR VEIN CONSISTENT WITH INCOMPLETE FRACTURE. PATIENT HAD THE PORT REMOVED ON (B)(6) 2019 AND REPLACED WITH THE SAME TYPE OF CATHETER. THE OUTCOME OF THE EVENT WAS RESOLVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    772947 PORT-A-CATH IMPLANTABLE ACCESS SYSTEM PORT AND CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAV LJT ST PAUL 3826325 10610586032776

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Female Required Intervention