BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BARD POWERPORT IMPLANTABLE PORT

    MDR report key: 10770237 · Received October 30, 2020

    Report

    Report Number
    MW5097580
    Event Type
    Injury
    Date Received
    October 30, 2020
    Date of Event
    October 27, 2020
    Report Date
    October 28, 2020
    Manufacturer
    BARD ACCESS SYSTEMS, INC.
    Product Code
    LJT
    UDI-DI
    00801741026577
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CO, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    SURGEON WAS PLACING A CHEST PORT USING BARD ACCESS SYSTEMS POWER PORT IMPLANTABLE PORT. REF (B)(4), LOT REEQ4128. THE GUIDE WIRE WAS INSERTED THROUGH THE NEEDLE INTO THE SUBCLAVIAN, THE INTRODUCER WAS PLACED OVER THE GUIDE WIRE. WHEN THE WIRE WAS BEING REMOVED, IT GAVE A SMALL AMOUNT OF RESISTANCE. THE WIRE WAS CAREFULLY REMOVED AND EXAMINED. IT HAD FRAYED, ALTHOUGH ALL PIECES WERE STILL ATTACHED, THE COMPONENTS OF THE WIRE UNWRAPPED. THE PORT WAS SUBSEQUENTLY PLACED. XRAYS SHOWED NO RETAINED FOREIGN BODY AND PORT IN GOOD POSITION. NO HARM CAME TO THE PATIENT. FDA SAFETY REPORT ID# (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1231675 BARD POWERPORT IMPLANTABLE PORT PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR LJT BARD ACCESS SYSTEMS, INC. 1708000 REEQ4128 00801741026577

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Required Intervention