BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CELSITE ACCESS PORT

    MDR report key: 5137848 · Received September 18, 2015

    Report

    Report Number
    9612452-2015-00022
    Event Type
    Injury
    Date Received
    September 18, 2015
    Date of Event
    August 17, 2015
    Report Date
    September 17, 2015
    Manufacturer
    B. BRAUN MEDICAL SAS
    Product Code
    LJT
    PMA / PMN Number
    K130576
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHARMACIST

    Narratives

    Additional Manufacturer Narrative · 1

    BATCH HISTORY REVIEW: THE MANUFACTURING FILE WAS REVIEWED. IT IS COMPLIANT WITH OUR SPECIFICATIONS AND NO ABNORMALITY WAS DETECTED. NO OTHER COMPLAINT WAS REPORTED ON THIS BATCH OF ACCESS PORTS. INVESTIGATION: DESPITE REQUESTS, NOR THE INVOLVED DEVICE NOR THE X-RAYS PICTURED WERE RETURNED FOR ANALYSIS. NO INVESTIGATION CAN BE PERFORMED. CONCLUSION: NO CONCLUSION CAN BE DRAWN. THE COMPLAINT HANDLING DATABASE DOES NOT SHOW ANY INCREASING TREND FOR THIS TYPE OF ACCESS PORT. NO CORRECTIVE ACTION IS ENVISAGED.

    Description of Event or Problem · 1

    "DURING ADMINISTRATION OF "DECITIENE", SWELLING OF THE PATIENT SKIN AROUND THE ACCESS PORT. SKIN REDNESS AND IRRITATION. LEAKAGE DUE TO CATHETER/PORT DISCONNECTION."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    620279 CELSITE ACCESS PORT ACCESS PORT SYSTEM LJT B. BRAUN MEDICAL SAS NA 36894591

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention