BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CELSITE ACCESS PORT

    MDR report key: 3879498 · Received May 28, 2014

    Report

    Report Number
    9612452-2014-00012
    Event Type
    Injury
    Date Received
    May 28, 2014
    Date of Event
    April 28, 2014
    Report Date
    May 27, 2014
    Manufacturer
    B. BRAUN MEDICAL SAS
    Product Code
    LJT
    PMA / PMN Number
    K130576
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TW
    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 USE ON THIS BATCH OF ACCESS PORTS, SOLD SINCE AUGUST 2011. INVESTIGATION RESULTS: THE DEVICE WAS RECEIVED FOR ANALYSIS. THE CATHETER RUPTURE OCCURRED AT 6CM OF THE ACCESS PORT HOUSING. THE RUPTURE IS NOT CLEAR. ONE PART SEEMS TO HAVE BEEN CUT (FACIES CLEAR) AND THE OTHER PART SEEMS TO HAVE BEEN RIPPED (FACIES MORE ROUGH). CONCLUSION: THE EXAMINATION OF THE CATHETER DID NOT ALLOW US TO DETERMINE THE EXACT ROOT CAUSE OF THE RUPTURE. THE RUPTURE FACIES IS UNUSUAL. THE APPROACH USED BY THE PHYSICIAN IS UNKNOWN AND THE X-RAY PICTURE ARE NOT AVAILABLE FOR EVALUATION. CONSEQUENTLY, NO CONCLUSION CAN BE DRAWN. AS AN ISOLATED CASE, NO CORRECTIVE ACTION IS ENVISAGED.

    Description of Event or Problem · 1

    ON (B)(6) 2012: IMPLANTATION OF THE ACCESS PORT. ON (B)(6) 2014: THE FLUSH OF THE PORT WAS NOT SUCCESSFUL AND PATIENT'S ARM WAS SWELLING. THE PORT WAS REMOVED AND IT WAS FOUND THE CATHETER BROKE AT 5CM APART FROM THE JUNCTION OF EXIT CANULA. ON (B)(6) 2014: THE PATIENT WAS SENT TO OPERATION TO REMOVE THE DISTAL TIP OF THE CATHETER. THE PATIENT WAS FOLLOWED UP FOR RECOVER ON (B)(6) AND RECOVERED WELL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    314181 CELSITE ACCESS PORT ACCESS PORT SYSTEM LJT B. BRAUN MEDICAL SAS ST305 K2008470

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Required Intervention