BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CELSITE

    MDR report key: 6342911 · Received February 20, 2017

    Report

    Report Number
    9612452-2017-00010
    Event Type
    Injury
    Date Received
    February 20, 2017
    Report Date
    February 17, 2017
    Manufacturer
    B .BRAUN MEDICAL SAS
    Product Code
    LJT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT REFERENCE (B)(4) IS NOT CLEARED FOR SALE IN USA, BUT IT IS SIMILAR TO THE PRODUCT REFERENCE (B)(4) CLEARED UNDER#510 K130576. BATCH HISTORY REVIEW: THE MANUFACTURING FILE WAS REVIEWED. IT IS COMPLIANT WITH THE SPECIFICATIONS AND NO ABNORMALITY WAS DETECTED. NO SIMILAR COMPLAINT WAS REPORTED ON THIS BATCH OF ACCESS PORTS. CONCLUSION: DESPITE REQUESTS, NO FURTHER INFORMATION HAS BEEN PROVIDED TO THE MANUFACTURER FOR EVALUATION. THE DEVICE IS NOT AVAILABLE FOR ANALYSIS. CONSEQUENTLY NO ROOT CAUSE ANALYSIS COULD BE PERFORMED. NO CORRECTIVE ACTION IS ENVISAGED.

    Description of Event or Problem · 1

    THE PATIENT REPORTED THAT HER PORT WAS IMPLANTED ON (B)(6) 2015. SHORTLY AFTER THE IMPLANTATION THE PORT AND CATHETER SEPARATED. BECAUSE THE REMOVAL WAS COMPLICATED THE PATIENT RECEIVED ADDITIONAL RADIATION AND SURGERY AND SUFFERED PSCHOLOGICAL AND FAMILY PROBLEMS

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    125723 CELSITE ACCESS PORT SYSTEM LJT B .BRAUN MEDICAL SAS 4433750 36902167

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization