BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CELSITE

    MDR report key: 6763030 · Received August 3, 2017

    Report

    Report Number
    9612452-2017-00026
    Event Type
    Injury
    Date Received
    August 3, 2017
    Report Date
    May 24, 2017
    Manufacturer
    B .BRAUN MEDICAL SAS
    Product Code
    LJT
    UDI-DI
    04038653917457
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHARMACIST

    Narratives

    Additional Manufacturer Narrative · 1

    NOTE: 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 COMPLAINT SAMPLE OR THE X-RAY PICTURES FOR INVESTIGATION, NO THOROUGH INVESTIGATION IS POSSIBLE AND IT IS NOT POSSIBLE TO CONCLUDE ON THE ROOT CAUSE OF THE INCIDENT ENCOUNTERED BY OUR CUSTOMER. 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

    CATHETER DISCONNECTED FROM THE ACCESS PORT. SECOND CASE IN THE SAME HOSPITAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    545216 CELSITE ACCESS PORT SYSTEM LJT B .BRAUN MEDICAL SAS 4430893 36896052 04038653917457

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention