BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CELSITE

    MDR report key: 6762762 · Received August 3, 2017

    Report

    Report Number
    9612452-2017-00032
    Event Type
    Injury
    Date Received
    August 3, 2017
    Report Date
    July 7, 2017
    Manufacturer
    B .BRAUN MEDICAL SAS
    Product Code
    LJT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHARMACIST

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT REFERENCE (B)(4) IS NOT CLEARED FOR SALES IN THE USA, BUT ITS CATHETER IS SIMILAR TO THE PRODUCT REFERENCE (B)(4) CLEARED UNDER #510 K130576. 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, NEITHER 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 DISCONNECTION. HOWEVER IT IS WORTH NOTING THAT CATHETER DISCONNECTION IS A KNOWN RISK OF ACCESS PORT IMPLANTATION AND, IN THIS CASE, IT HAPPENED LESS THAN 2 MONTHS AFTER THE IMPLANTATION. THIS LEADS US TO HYPOTHESISE THAT THE CATHETER WAS POTENTIALLY NOT CORRECTLY CONNECTED TO THE DEVICE BY THE USER AND THE REPETITIVE MOVEMENTS OF THE PATIENT LED TO THIS PREMATURE DISCONNECTION. ONLY THE EVALUATION OF THE INVOLVED DEVICE COULD ALLOW TO CONFIRM THIS HYPOTHESIS. THE IFU'S SPECIFY HOW TO CONNECT THE CATHETER TO THE ACCESS PORT AND THE RISKS OF INCORRECT CONNECTION. 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

    PLACEMENT OF A GRIPPER, PAIN DURING INJECTION OF A PRE-FILLED SYRINGE, ATTEMPT TO RE-POSITION THE GRIPPER. OEDEMA ABOVE THE ACCESS PORT. DISCUSSED WITH DR (B)(6), TAKE A FRONTAL CHEST XRAY WITH AND WITHOUT CONTRAST MEDIUM. 11.15 THE PATIENT WAS TAKEN TO X-RAY, RESULT WAS DISCONNECTION OF THE CATHETER FROM THE ACCESS PORT (PORT PLACED THE (B)(6) 2017) ECG PERFORMED, TRANSFER OF PATIENT TO USC ABOUT 4PM BY A NURSE THEN TRANSFERRED THE NEXT DAY FOR 8.30 APPOINTMENT WITH DR (B)(6), (B)(6).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    544580 CELSITE ACCESS PORT SYSTEM LJT B .BRAUN MEDICAL SAS 4430893 36915645

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention