BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CELSITE ACCESS PORT

    MDR report key: 5091428 · Received September 14, 2015

    Report

    Report Number
    9612452-2015-00020
    Event Type
    Injury
    Date Received
    September 14, 2015
    Date of Event
    July 1, 2015
    Report Date
    September 11, 2015
    Manufacturer
    B. BRAUN MEDICAL SAS
    Product Code
    LJT
    PMA / PMN Number
    130576
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    BATCH HISTORY REVIEW: (B)(4) OTHER SIMILAR INCIDENT WAS DECLARED TO US CONCERNING THIS BATCH OF ACCESS PORTS BY THE SAME HOSPITAL IN (B)(6). THE RAW MATERIAL CERTIFICATES, THE MFR'G AND STERILIZATION PROCESSES HAVE BEEN REVIEWED. NO ABNORMALITY HAS BEEN DETECTED. INVESTIGATION: THE INVOLVED DEVICE HAS BEEN RETURNED FOR EVALUATION. IT PRESENTS NO ASPECT DEFECT. IT IS COMPLIANT W/THE SPECIFICATIONS. CONCLUSION: THE COLLECTED INFO DID NOT ALLOW 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 RARE INCIDENT. NO CORRECTIVE ACTION IS ENVISAGED. IT IS WORTH NOTHING THAT THE CELSITE T501L 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

    EXTERIORIZATION OF ACCESS PORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    607871 CELSITE ACCESS PORT ACCESS PORT SYSTEM LJT B. BRAUN MEDICAL SAS ST501L 36890289

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention