BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BARD

    MDR report key: 2052941 · Received April 7, 2011

    Report

    Report Number
    MW5020219
    Event Type
    Malfunction
    Date Received
    April 7, 2011
    Date of Event
    February 28, 2011
    Report Date
    April 7, 2011
    Manufacturer
    UNK
    Product Code
    LJT
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    PA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    A PORT WAS PLACED IN THE PERITONEUM FOR ADMINISTRATION OF CHEMO IN (B)(6) 2010. THE PT'S CHEMO COURSE WAS COMPLETED AND SHE HAD HER PORT REMOVED (B)(6), 2011. AS PART OF THE PROCEDURE, A POST PROCEDURE X-RAY IS COMPLETED. THE X-RAY SHOWED THAT A PIECE OF THE PORT WAS LEFT BEHIND IN THE SUBCUTANEOUS TISSUE AND THE PT RETURNED TO HAVE IT REMOVED (B)(6), 2011. NO OPERATOR ERROR WAS FOUND.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BARD LV VEN ATTACH PLAS PORT LJT UNK RETC0639

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR