BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ARROW POLYSITE PRESSURE INJECTABLE IMPLANTABLE INFUSION PORT

    MDR report key: 8912180 · Received August 19, 2019

    Report

    Report Number
    MW5089175
    Event Type
    Injury
    Date Received
    August 19, 2019
    Date of Event
    August 13, 2019
    Report Date
    August 15, 2019
    Manufacturer
    PEROUSE MEDICAL
    Product Code
    LJT
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    AZ, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    IMPLANTABLE INFUSION PORT PLACED ON (B)(6) 2019; PLACEMENT WAS CONFIRMED BY IMAGING AND PATENCY ESTABLISHED. ON (B)(6) 2019 AN ATTEMPT TO ACCESS THE PORT AT AN OUTSIDE FACILITY WAS REPORTED TO BE UNSUCCESSFUL; IMAGES ON (B)(6) 2019 SHOWED THE CATHETER AND PORT WERE SEPARATED. THE DEVICE WAS REMOVED ON (B)(6) AND REPLACED (B)(6) 2019. OF NOTE, BUT NOT DIRECTLY RELATED TO THIS EVENT: WHEN THE KIT THAT WAS USED FOR THIS CASE WAS OPENED, THE CIRCULAR METAL RING AROUND ONE OF THE WHITE-TIPPED CONNECTION RINGS HAD FALLEN OFF THE TIP, MAKING IT UNUSABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    698813 ARROW POLYSITE PRESSURE INJECTABLE IMPLANTABLE INFUSION PORT PORT & CATHETER, IMPLANTED, SUBCUTANEOUS LJT PEROUSE MEDICAL 4018SPI

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR Required Intervention