BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CELSITE ACCESS PORT

    MDR report key: 3682619 · Received February 27, 2014

    Report

    Report Number
    9612452-2014-00004
    Event Type
    Injury
    Date Received
    February 27, 2014
    Date of Event
    October 8, 2012
    Report Date
    February 27, 2014
    Manufacturer
    B. BRAUN MEDICAL SAS
    Product Code
    LJT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AU
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    BATCH REVIEW: WE HAVE CHECKED THE MANUFACTURING FILE OF THIS LOT OF CELSITE ACCESS PORTS, WHICH COMPLIES WITH OUR SPECIFICATIONS AND DOES NOT PRESENT ANY ABNORMALITY. NO OTHER SIMILAR INCIDENTS WERE DECLARED TO US CONCERNING THIS LOT OF ACCESS PORTS, SOLD SINCE (B)(4) 2012. INVESTIGATION RESULTS: THE DEVICE WAS NOT RETURNED FOR EVALUATION. NO X-RAY PICTURE WAS FORWARDED TO US FOR EXAMINATION. CONCLUSION: THE DEVICE WAS NOT RETURNED FOR EVALUATION. CONSEQUENTLY WE CANNOT PERFORM AN IN-DEPTH INVESTIGATION AND COME THE ROOT CAUSE OF THIS INCIDENT. NO OTHER COMPLAINT HAS BEEN REPORTED TO US ON THIS BATCH. NO CORRECTIVE ACTION ENVISAGED. IT IS WORTH NOTING THAT THE CELSITE ST201F ACCESS PORT, REFERENCE (B)(4) IS NOT CLEARED IN THE U.S., BUT THIS DEVICE HAS THE SAME CATHETER AND CONNECTION SYSTEM THAN THE REFERENCE (B)(4) (K130576).

    Description of Event or Problem · 1

    (B)(6) 2012: CELSITE ST201F IMPLANTED IN PATIENT VIA RIGHT SUB-CLAVIAN VEIN. (B)(6) 2012: IMPOSSIBLE TO ADMINISTER THE CHEMOTHERAPY THROUGH THE PORT, DETECTED AT THE (B)(6). PORT DYSFUNCTION NOTED. (B)(6) 2013: ANGIOGRAPHY SHOWING THE DISCONNECTION OF CATHETER. (B)(6) 2012: REMOVAL OF ACCESS PORT AND THE CATHETER. ANOTHER ACCESS PORT IS PLACED IN THE LEFT SIDE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    122161 CELSITE ACCESS PORT ACCESS PORT SYSTEM LJT B. BRAUN MEDICAL SAS NA L1643650

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Required Intervention