BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CELSITE

    MDR report key: 11177567 · Received January 15, 2021

    Report

    Report Number
    9612452-2021-00007
    Event Type
    Malfunction
    Date Received
    January 15, 2021
    Date of Event
    December 14, 2020
    Report Date
    January 14, 2020
    Manufacturer
    B.BRAUN MEDICAL SAS
    Product Code
    LJT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    NOTE: PRODUCT REFERENCE (B)(4) IS NOT CLEARED FOR SALES IN THE USA, BUT IT IS SIMILAR TO THE PRODUCT REFERENCE (B)(4) CLEARED UNDER #510K130576. BATCH HISTORY REVIEW: WE HAVE CHECKED THE MANUFACTURING FILE OF THE INVOLVED BATCH WHICH COMPLIES WITH OUR SPECIFICATIONS AND DOES NOT PRESENT ANY DISCREPANCY. NO OTHER SIMILAR COMPLAINT HAS BEEN REPORTED TO US ON THIS BATCH RELEASED IN JULY 2020 INVESTIGATION: DESPITE OUR REQUESTS, THE DEVICE WAS NOT RETURNED FOR ANALYSIS. NO X-RAYS FILMS OR MEDICAL REPORTS ARE CURRENTLY AVAILABLE. THE INFORMATION RECEIVED ARE NOT SUFFICIENT TO PERFORM A THOROUGH INVESTIGATION. NO CONCLUSION CAN BE DRAWN ABOUT THE ROOT CAUSE. THIS TYPE OF INCIDENT IS A KNOWN POTENTIAL ADVERSE EVENT OF THE IMPLANTATION OF ACCESS PORTS. THIS IS A RARE INCIDENT. NO CORRECTIVE ACTION IS ENVISAGED.

    Description of Event or Problem · 1

    "THE PATIENT WAS SENT TO THE OPERATING ROOM ON (B)(6) 2020. MODIFIED RADICAL MASTECTOMY AND RIGHT BREAST MULTIPLE FIBROMA RESECTION WERE PERFORMED UNDER INTRATRACHEAL ANESTHESIA. THE POSTOPERATIVE PATHOLOGICAL DIAGNOSIS: SPECIMEN AFTER RESECTION OF LEFT BREAST TUMOR. THERE WAS NO CANCER IN THE NIPPLE, THE SURROUNDING SKIN INCISION, THE BREAST TISSUE AROUND THE ORIGINAL INCISION AND THE EXFOLIATED EDGE. NO CANCER WAS FOUND IN 2 LYMPH NODES OF "AXILLARY TISSUE". METASTASIS WAS FOUND IN 13 / 24 LEFT AXILLARY LYMPH NODES. POSTOPERATIVE CHEMOTHERAPY, RADIOTHERAPY WERE NEEDED. IN ORDER TO AVOID PERIPHERAL PHLEBITIS, CHEMOTHERAPY WAS STARTED AFTER THE PORT WAS IMPLANTED. IN THE SIXTH CYCLE OF CHEMOTHERAPY, IT WAS FOUND THAT THE SILICONE TUBE OF THE PORT FELL OFF AND THE END OF THE TUBE FELL OFF TO THE RIGHT ATRIUM. THEREFORE, THE INTERVENTIONAL DEPARTMENT WAS INVITED TO CONSULT AND ASSIST IN THE REMOVAL OF SILICONE TUBE. THE OPERATION WAS SUCCESSFUL."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    75732 CELSITE ACCESS PORT SYSTEM LJT B.BRAUN MEDICAL SAS 4430095 36962144

    Patients

    Seq Age Sex Outcome Treatment
    1