BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BARD PORT AND CATHETER IMPLANTED SUBCUTANEOUS

    MDR report key: 7957028 · Received October 10, 2018

    Report

    Report Number
    MW5080479
    Event Type
    Injury
    Date Received
    October 10, 2018
    Date of Event
    September 25, 2018
    Report Date
    October 8, 2018
    Manufacturer
    BARD / C. R. BARD, INC.
    Product Code
    PXK
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    A (B)(6) Y/O FEMALE PT WITH HISTORY OF LEFT BREAST CANCER, WHO IS S/P MEDIPORT INSERTION EARLIER THIS YEAR IN (B)(6). SHE HAS BEEN UNDERGOING NEOADJUVANT CHEMOTHERAPY. TODAY, IT WAS NOTED BY HER MEDICAL ONCOLOGIST THAT THE CATHETER DID NOT HAVE A GOOD BACKFLOW. ACCORDING TO DR (B)(6) (ONCOLOGIST), THE CATHETER WAS FLUSHED WITH SALINE, AND HE IMMEDIATELY NOTICED SLIGHT SWELLING IN THE SUBCUTANEOUS POCKET AREA. THE PT WAS THUS BROUGHT IN FOR WOUND EXPLORATION, FLUOROSCOPY, EVALUATION/REVISION OF THE MEDIPORT, POSSIBLE REMOVAL. DURING THE SURGERY, IT WAS FOUND THAT THE CATHETER WAS DISRUPTED BETWEEN 5 AND 6 CM FROM THE TIP, AND ON FLUOROSCOPIC VIEW, THE CATHETER TIP WAS FOUND TO BE RETAINED IN THE RIGHT ATRIUM. THE REMAINING CATHETER AND PORT WERE REMOVED AND TRANSFERRED TO HIGHER LEVEL OF CARE FOR FOREIGN BODY REMOVAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    793316 BARD PORT AND CATHETER IMPLANTED SUBCUTANEOUS MEDIPORT II MODEL MP-DL VASCULAR ACCESS PORT PXK BARD / C. R. BARD, INC. 2864

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR Required Intervention