BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CELSITE ACCESS PORT

    MDR report key: 3906493 · Received June 13, 2014

    Report

    Report Number
    9612452-2014-00014
    Event Type
    Injury
    Date Received
    June 13, 2014
    Date of Event
    May 7, 2014
    Report Date
    June 13, 2014
    Manufacturer
    B. BRAUN MEDICAL SAS
    Product Code
    LJT
    PMA / PMN Number
    K130576
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHARMACIST

    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 (B)(4) 2014. INVESTIGATION RESULTS: THE ACCESS PORT WITHOUT CATHETER WAS RECEIVED FOR ANALYSIS. A LEAK PROOF TEST HAS BEEN PERFORMED ON IT. NO LEAK HAS BEEN DETECTED. NO MANUFACTURING DEFECT IS VISIBLE. CONCLUSION: THE RETURNED ACCESS PORT HOUSING IS WITHIN SPECIFICATION. WITHOUT THE COMPLETE DEVICE, WE CANNOT CONFIRM THE COMPLAINT. IT IS WORTH NOTING THAT THE CELSITE ST201F ACCESS PORT, REFERENCE (B)(4) IS NOT CLEARED IN THE US, BUT THIS DEVICE HAS THE SAME CATHETER THAN THE ACCESS PORT REFERENCE #(B)(4).

    Description of Event or Problem · 1

    LEAKAGE DETECTED DURING THE FIRST USE OF THE ACCESS PORT. ACCESS PORT REMOVED AND REPLACED BY ANOTHER ONE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    350607 CELSITE ACCESS PORT ACCESS PORT SYSTEM LJT B. BRAUN MEDICAL SAS ST201F M354975T

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention