BEUDAMED
    FDA Adverse Event Injury Summary report: N

    8 FRENCH POWER PORT

    MDR report key: 3874100 · Received June 10, 2014

    Report

    Report Number
    MW5036585
    Event Type
    Injury
    Date Received
    June 10, 2014
    Date of Event
    February 28, 2014
    Report Date
    June 9, 2014
    Manufacturer
    BARD
    Product Code
    LJT
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    VT, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    IR CENTRAL LINE STUDY WITH CONTRAST FOUND 8 FRENCH BARD PORT-A-CATH INSERTED INTO LEFT CHEST WALL (B)(6) 2011 TO HAVE CRACKED TUBING THAT LEAKED CONTRAST. DATES OF USE: (B)(6) 2011 - (B)(6) 2014. DIAGNOSIS OR REASON FOR USE: CHEMO FOR BREAST CANCER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    337912 8 FRENCH POWER PORT POWER PORT LJT BARD POWER PORT IMPLANT REVJ1441

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Required Intervention