BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CELSITE

    MDR report key: 6639429 · Received June 14, 2017

    Report

    Report Number
    9612452-2017-00030
    Event Type
    Injury
    Date Received
    June 14, 2017
    Date of Event
    April 24, 2017
    Report Date
    June 13, 2017
    Manufacturer
    B .BRAUN MEDICAL SAS
    Product Code
    LJT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT REFERENCE (B)(4) IS NOT CLEARED FOR SALES IN THE USA, BUT ITS CATHETER IS SIMILAR TO THE PRODUCT REFERENCE (B)(4) CLEARED UNDER #510 K130576. BATCH HISTORY REVIEW: THE MANUFACTURING FILE WAS REVIEWED. IT IS COMPLIANT WITH OUR SPECIFICATIONS AND NO ABNORMALITY WAS DETECTED. NO OTHER SIMILAR COMPLAINT WAS REPORTED ON THIS BATCH OF ACCESS PORTS. INVESTIGATION: DESPITE SEVERAL REQUESTS, NEITHER THE INVOLVED DEVICE NOR THE X-RAY PICTURES WERE RETURNED FOR ANALYSIS. CONCLUSION: WITHOUT THE DEVICE FOR EVALUATION, NO CONCLUSION CAN BE DRAWN CONCERNING THE EXACT ROOT CAUSE OF THE CATHETER DISCONNECTION. B BRAUN (B)(4) HAS PROVIDED ALL THE INFORMATION CURRENTLY AVAILABLE TO US. IN SPITE OF ALL REASONABLE EFFORTS BEING MADE TO OBTAIN FURTHER INFORMATION OR THE DEVICE, AT THIS TIME WE HAVE NOT MET WITH SUCCESS.

    Description of Event or Problem · 1

    DURING A CHECK VISIT ON (B)(6), DISCOVERY OF A DISCONNECTION OF THE CATHETER FROM THE ACCESS PORT THE PATIENT SAID THAT FOR ABOUT 10 DAYS HE HADN'T FELT THE CATHETER. NO FALL OR SHOCK WHICH COULD EXPLAIN THE DISCONNECTION OCCURRED. DURING THE PREVIOUS VISIT IN FEBRUARY, THERE WAS NO SIGN OF DISCONNECTION. MIGRATION OF THE CATHETER FROM THE SUB CLAVICULAR REGION TO THE RIGHT VENTRICLE WAS SHOWN ON CHEST X-RAY. THE ACCESS PORT WAS IMPLANTED THE (B)(6) 2016 (NO CHEMOTHERAPY TREATMENT FOR 9 MONTHS).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    421593 CELSITE ACCESS PORT SYSTEM LJT B .BRAUN MEDICAL SAS 36906433

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention