BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    POWERPORT

    MDR report key: 6102594 · Received November 15, 2016

    Report

    Report Number
    6102594
    Event Type
    Malfunction
    Date Received
    November 15, 2016
    Date of Event
    July 7, 2016
    Report Date
    October 4, 2016
    Manufacturer
    BARD ACCESS SYSTEMS, INC.
    Product Code
    LJT
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    RI, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    A PATIENT WAS SENT TO VASCULAR INTERVENTIONAL RADIOLOGY FOR PORT REMOVAL. THE PROCEDURE WAS TOLERATED WELL AND ALL PROTOCOLS FOR PORT REMOVAL FOLLOWED. LATER THAT DAY, UPON FURTHER REVIEW OF IMAGING, IT WAS IDENTIFIED THAT A SMALL FOREIGN BODY WAS RETAINED IN THE ADIPOSE TISSUE OF THE PATIENT. THE LOCATION OF THE OBJECT POSES NO HARM TO THE PATIENT, WHO DECLINED TO HAVE IT REMOVED. THIS OBJECT IS BELIEVED TO BE A SMALL HUB, WHICH IS NOT RADIOPAQUE. OF NOTE, THE PORT WAS REMOVED INTACT, IN GOOD CONDITION, THERE ARE NO BREAKS, CRACKS, FRAYS, TEARS, CHIPS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    753538 POWERPORT PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR LJT BARD ACCESS SYSTEMS, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 83 YR Other