BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CELSITE

    MDR report key: 9936764 · Received April 8, 2020

    Report

    Report Number
    9612452-2020-00014
    Event Type
    Injury
    Date Received
    April 8, 2020
    Date of Event
    January 30, 2020
    Report Date
    April 3, 2020
    Manufacturer
    B.BRAUN MEDICAL SAS
    Product Code
    LJT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT REFERENCE 4430095 IS NOT CLEARED FOR SALES IN THE USA, BUT ITS CATHETER IS SIMILAR TO THE PRODUCT REFERENCE 5430095 CLEARED UNDER #510/K130576. THE INVOLVED SAMPLE, NOR X-RAY PICTURESARE AVAILABLE FOR INVESTIGATION. THE BATCH NUMBER IS UNKNOWN. WITHOUT THE NECESSARY ELEMENTS FOR INVESTIGATION, WE CANNOT PERFORM ANY INVESTIGATION AND CONCLUDE ON THE ROOT CAUSE OF THIS INCIDENT. THE CATHETER RUPTURE IS A KNOWN COMPLICATION OF THE ACCESS PORT IMPLANTATION THAT COULD BE HAVE DIFFERENT ROOT CAUSES. THIS IS A RARE INCIDENT; NO CORRECTIVE ACTION IS ENVISAGED. HOWEVER, IF NEW ELEMENTS BECOME AVAILABLE, THIS COMPLAINT WILL BE RE-OPENED.

    Description of Event or Problem · 1

    "AFTER DRUG INFUSION TREATMENT THROUGH THE ACCESS PORT ON (B)(6) 2019, THE PATIENT'S RIGHT NECK WAS SWOLLEN. ON (B)(6) 2019, THE ACCESS PORT WAS REMOVED IN THE EMERGENCY ROOM AND A RUPTURE WAS FOUND 11.5 CM AWAY FROM THE CATHETER, WHICH WAS COMPLETELY REMOVED."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    401379 CELSITE ACCESS PORT SYSTEM LJT B.BRAUN MEDICAL SAS 01314430095 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention