BEUDAMED
    FDA Adverse Event Injury Summary report: N

    6.6F DIGNITY CT PORT

    MDR report key: 2121016 · Received June 9, 2011

    Report

    Report Number
    2518902-2011-00062
    Event Type
    Injury
    Date Received
    June 9, 2011
    Date of Event
    May 2, 2011
    Report Date
    June 8, 2011
    Manufacturer
    MEDCOMP
    Product Code
    LJT
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    AN INVESTIGATION HAS BEEN INITIATED. A REVIEW OF THE MANUFACTURING RECORDS INDICATED THAT ALL DEVICE SPECIFICATIONS AND QUALITY REQUIREMENTS WERE SATISFIED. WHEN THE INVESTIGATION IS COMPLETE A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT "A NEEDLE WAS INSERTED INTO THE PORT ON (B)(6) 2011 IN ORDER TO ADMINISTER CHEMOTHERAPY. THE MEDICAL STAFF NOTICED SWELLING AROUND THE PORT UNDER THE SKIN AND THE PATIENT CRIED THE WHOLE TIME. LIQUID WAS INSERTED THROUGH THE NEEDLE, THE DAY AFTER THE PATIENT HAD A FEVER. AN X-RAY WAS MADE OF THE SPOT AND NOTHING UNUSUAL WAS FOUND. DUE TO THE CONTINUED SWELLING, INTRA VENOUS LINE WAS STOPPED THROUGH THE PORT. PORT WAS REMOVED ON (B)(6) 2011 AND THE MEDICAL STAFF DISCOVERED THAT THE NEEDLE PERFORATED THE PORT BOX."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 6.6F DIGNITY CT PORT POWER INJECTABLE INFUSION PORT LJT MEDCOMP MRCTI66841 MBAR470

    Patients

    Seq Age Sex Outcome Treatment
    1 2 YR Required Intervention HUBER NEEDLE