BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CELSITE ACCESS PORT

    MDR report key: 3760999 · Received April 11, 2014

    Report

    Report Number
    9612452-2014-00010
    Event Type
    Injury
    Date Received
    April 11, 2014
    Date of Event
    March 6, 2014
    Report Date
    April 10, 2014
    Manufacturer
    B. BRAUN MEDICAL SAS
    Product Code
    LJT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    BATCH HISTORY REVIEW: NO OTHER SIMILAR INCIDENTS WERE DECLARED TO US CONCERNING THIS BATCH OF ACCESS PORTS. INVESTIGATION: EITHER THE DEVICE NOR THE -XRAY PICTURES WERE RETURNED FOR EVAL. 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. NO CORRECTIVE ACTION IS ENVISAGED. IT IS WORTH NOTING THAT THE CELSITE T305 ACCESS PORT, REFERENCE 4436903 IS NOT CLEARED IN THE U.S., BUT THIS DEVICE IS SIMILAR TO THE REFERENCE 05433750 (K130576).

    Description of Event or Problem · 1

    ON 2010: PORT SYSTEM IMPLANTED FOR CHEMOTHERAPY. ON 2014: CATHETER FRACTURE DETECTED WITH DISPLACEMENT OF THE FRAGMENT IN THE PULMONARY ARTERY. THE FRAGMENT WAS REMOVED BY RADIOLOGICAL INTERVENTION. NO COMPLICATIONS NOTED. PT RELEASED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    220921 CELSITE ACCESS PORT ACCESS PORT SYSTEM LJT B. BRAUN MEDICAL SAS T305 G1592650

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Required Intervention