BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CELSITE ACCESS PORT

    MDR report key: 4890745 · Received July 1, 2015

    Report

    Report Number
    9612452-2015-00012
    Event Type
    Injury
    Date Received
    July 1, 2015
    Date of Event
    May 27, 2015
    Report Date
    June 26, 2015
    Manufacturer
    BBRAUN MEDICAL SAS
    Product Code
    LJT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE BATCH NUMBERS OF THE INVOLVED DEVICES ARE UNK. THE INFO CONCERNING THE IMPLANTATION AND THE UES OF THESE DEVICES WERE NOT FORWARDED TO THE MFR. THE DEVICES ARE NOT AVAILABLE FOR EVAL. CONCLUSION: DESPITE SEVERAL REQUESTS, NO ELEMENTS WERE SENT TO MFR FOR EVAL. NO THOROUGH INVESTIGATION CAN BE PERFORMED. IT IS WORTH NOTING THAT THE CELSITE CONCEPT ST505L ACCESS PORT, REFERENCE (B)(4) IS NOT CLEARED IN THE US, BUT THIS DEVICE IS SIMILAR TO THE REFERENCE (B)(4) (K130576).

    Description of Event or Problem · 1

    CATHETER DISCONNECTION FROM THE ACCESS PORT. MIGRATION OF THE CATHETER. INTERVENTION TO REMOVE THE CATHETER BY INTERVENTIONAL RADIOLOGY. THIS INCIDENT OCCURRED ON 3 DIFFERENT PTS, FOR WHICH THE ACCESS PORT WAS IMPLANTED BY THE SAME PHYSICIAN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    426317 CELSITE ACCESS PORT ACCESS PORT SYSTEM LJT BBRAUN MEDICAL SAS NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention