BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CELSITE ACCESS PORT

    MDR report key: 4898163 · Received July 6, 2015

    Report

    Report Number
    9612452-2015-00013
    Event Type
    Injury
    Date Received
    July 6, 2015
    Date of Event
    May 23, 2015
    Report Date
    July 2, 2015
    Manufacturer
    B. BRAUN MEDICAL SAS
    Product Code
    LJT
    PMA / PMN Number
    K130576
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    BATCH HISTORY REVIEW: THE MANUFACTURING FILE WAS REVIEWED. IT IS COMPLIANT WITH OUR SPECIFICATIONS AND NO ABNORMALITY WAS DETECTED. NO OTHER COMPLAINT FROM ANOTHER HEALTH FACILITY WAS REPORTED TO US ON THIS ACCESS PORTS BATCH. INVESTIGATION: TWO PIECES OF THE EXPLANTED CATHETER WERE RETURNED FOR EVALUATION. THE PORT WAS DISCARDED. THE CATHETER PRESENTS NO MANUFACTURING DEFECT. IT IS DIMENSIONALLY COMPLAINT WITH THE SPECIFICATION. DESPITE SEVERAL REQUESTS, NO INFO ABOUT IMPLANTATION PROCEDURE NOR X-RAY PICTURES HAVE BEEN FORWARDED TO THE MANUFACTURER. WITHOUT THESE INFO, NO THOROUGH INVESTIGATION CAN BE PERFORMED. NO CONCLUSION CAN BE DRAWN. IT IS WORTH NOTING THAT THE CELSITE ST301 ACCESS PORT, REFERENCE (B)(4) IS NOT CLEARED IN THE UNITED STATES, BUT THIS DEVICE IS THE SAME THAN THE REFERENCE (B)(4) (K130576).

    Description of Event or Problem · 1

    "THE CATHETER WAS DISCONNECTED OF THE PORT AND GO TO THE HEART OF THE PT. WHEN THE RADIOLOGIST WENT TO TAKE THE CATHETER OUT OF THE HEART, THE CATHETER BROKE IN 2 PIECES. WHEN HE WENT TO TAKE THE SECOND PIECE, THE CATHETER BROKE ONCE AGAIN IN 2 PIECES. THE LAST PART OF THE CATHETER IS ALWAYS IN THE HEART OF THE PT."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    436223 CELSITE ACCESS PORT ACCESS PORT SYSTEM LJT B. BRAUN MEDICAL SAS NA 36892505

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention