BEUDAMED
    FDA Adverse Event Injury Summary report: N

    POWER PORT IMPLANTABLE PORT

    MDR report key: 3060179 · Received April 11, 2013

    Report

    Report Number
    MW5029747
    Event Type
    Injury
    Date Received
    April 11, 2013
    Date of Event
    March 31, 2013
    Report Date
    April 9, 2013
    Manufacturer
    BARD ACCESS SYSTEMS, INC.
    Product Code
    LJT
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NJ, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PT NEEDED IV CONTRAST FOR CT SCAN OF ABDOMEN/PELVIS. PT HAD POWER INFUS-A-PORT WITH IDENTIFIERS (ACCEPTABLE FOR POWER INJECTION). THE RN ACCESSED THE POWER INFUS-A-PORT AND THE CT TECHNOLOGIST NOTED 2 IDENTIFIERS ON THE PORT (PT'S WRISTBAND AND 3 BUMPS INDICATING THE PORT IS "POWER" AS DESCRIBED BY BARD). THERE WAS NO PROBLEM WITH PATENCY, AS PORT WAS FLUSHED SEVERAL TIMES. THE CT SCAN WAS PERFORMED AT A RATE OF 2.5ML/SECOND. THERE WAS NO CONTRAST ENHANCEMENT AT THE TIME OF SCAN AND A SUBSEQUENT PORT. CHEST X-RAY REVEALED AN EXTRAVASATION INTO THE CHEST. CHEST CT REVEALED CONTRAST EXTRAVASATION FROM THE PORT INJECTION SITE OR PORT LEAKAGE. DATE OF USE: (B)(6) 2013 - (B)(6) 2013 AND 90CC.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    154796 POWER PORT IMPLANTABLE PORT POWER PORT LJT BARD ACCESS SYSTEMS, INC. 1809600 REWK0380

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR CHEMOTHERAPY - 4 DOSES BETWEEN (B)(6) 2013