BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CELSITE ACCESS PORT

    MDR report key: 3946368 · Received July 10, 2014

    Report

    Report Number
    9612452-2014-00015
    Event Type
    Injury
    Date Received
    July 10, 2014
    Date of Event
    June 5, 2014
    Report Date
    July 7, 2014
    Manufacturer
    B. BRAUN MEDICAL SAS
    Product Code
    LJT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    BATCH HISTORY REVIEW: THE BATCH HISTORY FILE COMPLIES WITH OUR SPECIFICATIONS AND DOES NOT PRESENT ANY DISCREPANCY. NO OTHER SIMILAR INCIDENT WAS DECLARED TO US ON THIS BATCH OF ACCESS PORTS, SOLD SINCE OCTOBER 2013. INVESTIGATION RESULTS: THE ACCESS PORT AND THE PROXIMAL PART OF THE CATHETER WERE RECEIVED FOR ANALYSIS. THE CATHETER RUPTURE OCCURRED AT THE LEVEL OF THE CONNECTION WITH THE PORT, OVER THE EXIT CANULA. THIS RUPTURE OCCURRED PROBABLY QUICKLY AFTER THE IMPLANTATION BECAUSE ONLY 5 PUNCTURE MARKS ARE VISIBLE IN THE SEPTUM. THE ASPECT OF THE RUPTURE IS UNUSUAL. THIS PART OF THE CATHETER IS PROTECTED BY THE CONNECTION RING DURING THE IMPLANTATION PERIOD. CONCLUSION: THE EXAMINATION OF THE CATHETER DID NOT ALLOW US TO DETERMINE THE ROOT CAUSE OF THIS PREMATURE RUPTURE. THE ASPECT OF THE RUPTURE IS UNUSUAL. NO INFORMATION CONCERNING THE IMPLANTATION IS AVAILABLE. CONSEQUENTLY, NO CONCLUSION CAN BE DRAWN. IT IS WORTH NOTING THAT THE CELSITE ST301F 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

    RUPTURE OF THE CATHETER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    403856 CELSITE ACCESS PORT ACCESS PORT SYSTEM LJT B. BRAUN MEDICAL SAS ST301F M2674090

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention