BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CELSITE

    MDR report key: 6511199 · Received April 21, 2017

    Report

    Report Number
    9612452-2017-00019
    Event Type
    Malfunction
    Date Received
    April 21, 2017
    Date of Event
    March 1, 2017
    Report Date
    April 21, 2017
    Manufacturer
    B .BRAUN MEDICAL SAS
    Product Code
    LJT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    NOTE: PRODUCT REFERENCE 4430893 IS NOT CLEARED FOR SALES IN THE USA, BUT IT IS SIMILAR TO THE PRODUCT REFERENCE 5433750 CLEARED UNDER #510K130576. BATCH HISTORY REVIEW: THE MANUFACTURING FILE WAS REVIEWED. IT IS COMPLIANT WITH OUR SPECIFICATIONS AND NO ABNORMALITY WAS DETECTED. NO OTHER SIMILAR COMPLAINT WAS REPORTED ON THIS BATCH OF ACCESS PORTS. INVESTIGATION: DESPITE SEVERAL REQUESTS, EITHER THE INVOLVED DEVICE NOR THE X-RAY PICTURES WERE RETURNED FOR ANALYSIS. CONCLUSION: WITHOUT THE DEVICE FOR EVALUATION, NO CONCLUSION CAN BE DRAWN CONCERNING THE EXACT ROOT CAUSE OF THE CATHETER RUPTURE DURING REMOVAL. HOWEVER THIS TYPE OF INCIDENT IS A KNOWN RISK OF ACCESS PORT IMPLANTATION. THE IFU SPECIFY THE PRECAUTIONS TO TAKE TO AVOID CATHETER FRACTURE DURING CATHETER REMOVAL, IN PARTICULAR WHEN THE CATHETER IS ENCAPSULATED OR ATTACHED TO THE VESSEL WALL. THIS IS A RARE INCIDENT, NO CORRECTIVE ACTION IS ENVISAGED. B BRAUN (B)(4) HAS PROVIDED ALL THE INFORMATION CURRENTLY AVAILABLE TO US. IN SPITE OF ALL REASONABLE EFFORTS BEING MADE TO OBTAIN FURTHER INFORMATION OR THE DEVICE, AT THIS TIME WE HAVE NOT MET WITH SUCCESS.

    Description of Event or Problem · 1

    ATTEMPT TO REMOVE AN ACCESS PORT, EXTERNAL JUGULAR, CLEAN BREAK 11 CM FROM THE TIP DURING TRACTION ON THE CATHETER FROM THE ACCESS PORT SIDE. THIS GENTLY TRACTION ALLOWED THE CATHETER TO COME OUT UNTIL IT RUPTURED. DEVICE KEPT. THE RETAINED CATHETER APPEARED TO BE FIXED TO THE SUPERIOR VENA CAVA AND WAS THEREFORE INACCESSIBLE BY (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    294021 CELSITE ACCESS PORT SYSTEM LJT B .BRAUN MEDICAL SAS 4430893 L3478100

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization