BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PORT-A-CATH BARD POWER PORT DUO MRI

    MDR report key: 11752165 · Received April 29, 2021

    Report

    Report Number
    MW5101081
    Event Type
    Injury
    Date Received
    April 29, 2021
    Date of Event
    April 19, 2021
    Report Date
    April 27, 2021
    Manufacturer
    BARD ACCESS SYSTEMS, INC.
    Product Code
    LJT
    UDI-DI
    00801741027192
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    IL, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    BARD POWER PORT DUO 9.5 F PLACED ON (B)(6) 2021. ON (B)(6) 2021 CT CHEST / ABDOMEN DONE WITH CONTRAST AT ANOTHER FACILITY. REPORTED NOTED THAT THERE WAS EXTRAVASATION IN THE PORT-A-CATH. PT PRESENTED TO HAVE PORT CHANGED. THIS PORT IS PART OF A URGENT MEDICAL RECALL BY BARD ACCESS SYSTEMS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    646150 PORT-A-CATH BARD POWER PORT DUO MRI PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR LJT BARD ACCESS SYSTEMS, INC. 1829570 REEX0568 00801741027192

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Required Intervention