BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CELSITE ACCESS PORT

    MDR report key: 3717198 · Received March 21, 2014

    Report

    Report Number
    9612452-2014-00009
    Event Type
    Injury
    Date Received
    March 21, 2014
    Date of Event
    January 21, 2014
    Report Date
    March 19, 2014
    Manufacturer
    B. BRAUN MEDICAL SAS
    Product Code
    LJT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    BATCH HISTORY REVIEW: NO OTHER SIMILAR INCIDENTS WERE DECLARED TO US CONCERNING THIS BATCH OF ACCESS PORTS. INVESTIGATION: NO DEVICE RETURNED FOR EVALUATION. CONCLUSION: THE ELEMENTS IN OUR POSSESSION CANNOT ALLOW US TO CONCLUDE ON THE ROOT CAUSE OF THIS INCIDENT. OUR COMPLAINT HANDLING DATABASE DOES NOT SHOW ANY INCREASING TREND FOR THIS TYPE OF COMPLAINT. IT IS AN ISOLATED CASE. NO CORRECTIVE ACTION IS ENVISAGED. IT IS WORTH NOTHING THAT THE CELSITE T305 ACCESS PORT, REFERENCE (B)(4) IS NOT CLEARED IN THE US, BUT THIS DEVICE HAS THE SAME CATHETER AS THE REFERENCE (B)(4) (K130576).

    Description of Event or Problem · 1

    INSERTION OF IMPLANTABLE ACCESS PORT ON THE PATIENT. THE SURGEON CHECKED THE BLOOD RETURN, WHICH WAS NOT POSSIBLE. THE SURGEON CONFIRMED DISTAL CATHETER PART MIGRATION. HE TRIED TO RETRIEVE THE CATHETER TIP, BUT IT WAS NOT POSSIBLE. THE SURGEON DECIDED TO SEND THE PATIENT TO THE CLINICA CARDIOVASCULAR TO WITHDRAW THE CATHETER BY INTERVENTIONAL RADIOLOGY. THE PATIENT IS STABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    168519 CELSITE ACCESS PORT ACCESS PORT SYSTEM LJT B. BRAUN MEDICAL SAS ST201F M163466T

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Required Intervention