BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BARD POWER PORT

    MDR report key: 2031335 · Received March 16, 2011

    Report

    Report Number
    2031335
    Event Type
    Injury
    Date Received
    March 16, 2011
    Date of Event
    March 1, 2011
    Report Date
    March 7, 2011
    Manufacturer
    BARD ACCESS SYSTEMS
    Product Code
    LJT
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    IL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    PT EXPERIENCED PAINFUL INJECTIONS UTILIZING THE POWER PORT. VENOGRAM ON (B)(6) 2011 REVEALED "CATHETER IS TOO SHORT AND THERE IS FIBRIN SHEATH AT THE END OF THE CATHETER ALONG THE PROXIMAL SUPERIOR VENA CAVAL WALL. THIS IS CAUSING OBSTRUCTION TO FLOW AS WELL." UPON REMOVAL OF THE POWER PORT, THE SURGEON REPORTED, "THE CATHETER HAD A LONG SPLIT OF 1CM PRESENT, APPROX 2 TO 3 CM FROM THE CONNECTION SITE TO THE PORT."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BARD POWER PORT BARD POWER PORT LJT BARD ACCESS SYSTEMS 1808000 REUE0231

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Hospitalization| R