BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CELSITE ACCESS PORT

    MDR report key: 5077982 · Received September 11, 2015

    Report

    Report Number
    9612452-2015-00019
    Event Type
    Injury
    Date Received
    September 11, 2015
    Date of Event
    July 22, 2015
    Report Date
    April 26, 2015
    Manufacturer
    B. BRAUN MEDICAL SAS
    Product Code
    LJT
    PMA / PMN Number
    K130576
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FI
    Reporter Occupation
    1

    Narratives

    Additional Manufacturer Narrative · 1

    BATCH HISTORY REVIEW: THE MFG FILE WAS REVIEWED. IT IS COMPLAINT WITH OUR SPECIFICATIONS AND NO ABNORMALITY WAS DETECTED. NO OTHER COMPLIANT WAS REPORTED ON THIS BATCH OF ACCESS PORTS. INVESTIGATION: THE RETURNED DEVICE IS COMPLAINT WITH THE SPECIFICATIONS. CONCLUSION: THE INVESTIGATION PERFORMED LEADS US TO THINK THAT THE CATHETER RUPTURE RESULTS FROM AN EROSION OF THE CATHETER AT THE LEVEL OF THE COLLARBONE OR DUE TO THE CATHETER ACUTE ANGLE AT ITS ENTRANCE IN THE JUGULAR VEIN.

    Description of Event or Problem · 1

    "PT (B)(6) CHILD. PORT HAS SET TO THE PT IN (B)(6) 2013 (WHEN CHILD WAS (B)(6)) WITHOUT PROBLEMS (V. JUG, INT, L.DX) PORT POCKET HAS PLACED TO THE RIB CAGE. THE PORT HAS WORKED PERFECTLY. ON (B)(6) 2015 THE PORT WAS RINSED BY USING 5 ML SYRINGE. THERE HAS BEEN A TROUBLE TO RINSE THE CATHETER. ON THE SAME TIME THEY HAVE NOTICED EXTRAVASATION ON THE NECK AREA. DUE TO THIS PROBLEM THE PORT HAS BEEN REMOVED WITH A PART OF CATHETER. THE CATHETER HAS BEEN BROKEN ABOUT 8 CM FROM THE PORT (NEAR BY THE POINT WHERE THE CATHETER HAS ENTERED TO THE VEIN). BASED ON THE X-RAY PICTURE OF THE LUNGS THEY FOUND THE REST OF CATHETER FROM THE INFERIOR VENA CAVA. ON (B)(6) IN THE ANGIOGRAPHY OPERATION THEY SUCCEEDED TO REMOVE THE REST OF CATHETER".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    603141 CELSITE ACCESS PORT ACCESS PORT SYSTEM LJT B. BRAUN MEDICAL SAS NA M099735T

    Patients

    Seq Age Sex Outcome Treatment
    1 2 YR Required Intervention