BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CELSITE

    MDR report key: 6059949 · Received October 27, 2016

    Report

    Report Number
    9612452-2016-00040
    Event Type
    Injury
    Date Received
    October 27, 2016
    Date of Event
    September 21, 2016
    Report Date
    October 25, 2016
    Manufacturer
    B.BRAUN MEDICAL SAS - OWNER
    Product Code
    LJT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHARMACIST

    Narratives

    Additional Manufacturer Narrative · 1

    NOTE: PRODUCT REFERENCE 4430893 IS NOT CLEARED IN USA, BUT IT IS SIMILAR TO THE PRODUCT REFERENCE 5433750 CLEARED UNDER #K130576. BATCH HISTORY REVIEW: THE MANUFACTURING FILE WAS REVIEWED. IT IS COMPLIANT WITH OUR SPECIFICATIONS AND NO ABNORMALITY WAS DETECTED. NO OTHER COMPLAINT WAS REPORTED ON THIS BATCH OF ACCESS PORTS. INVESTIGATION: THE INVOLVED DEVICE WAS RETURNED FOR EVALUATION. THE CATHETER IS BROKEN IN 2 PIECES. THE CATHETER RUPTURE HAPPENED ON THE EXIT CANNULA, IE UNDER THE CONNECTION RING. THE RUPTURE FACIES OF THE CATHETER IS VERY IRREGULAR. THE DIAMETERS HAVE BEEN MEASURED. ALL THE MEASUREMENTS ARE COMPLIANT WITH THE SPECIFICATIONS. THE CATHETER MATERIAL IS NOT DETERIORATED. NO VISIBLE MANUFACTURING DEFECT IS DETECTED. CONCLUSION: NO MANUFACTURING DEFECT WAS DETECTED ON THE INVOLVED DEVICE. THE FACIES IS IRREGULAR AT THE AREA OF THE RUPTURE, THE RUPTURE OCCURED UNDER THE CONNECTION RING, WHICH WOULD HAVE PROTECTED THE CATHETER AFTER IMPLANTATION. THIS IS AN ISOLATED CASE. ACCORDING TO THE ABOVE MENTIONED INFORMATION AND IN VIEW THE RAPIDITY OF THE RUPTURE, THE MOST PROBABLE ROOT CAUSE SEEMS TO BE THAT THE CATHETER HAS BEEN DAMAGED DURING THE IMPLANTATION, PROBABLY DURING CATHETER MOUNTING ON THE EXIT CATHETER. AS A VERY RARE INCIDENT, NO CORRECTIVE ACTION IS ENVISAGED.

    Description of Event or Problem · 1

    ON (B)(6) 2016: IMPLANTATION OF AN ACCESS PORT ON A PATIENT FOR ADMINISTRATION OF CHEMOTHERAPY TREATMENT. ON (B)(6) 2016: SWELLING DETECTED DURING THE INFUSION OF THE TREATMENT. AFTER RADIOGRAPHIC CHECKING, THE RUPTURE OF THE CATHETER IS NOTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    712159 CELSITE ACCESS PORT SYSTEM LJT B.BRAUN MEDICAL SAS - OWNER 4430893 36908899

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR Required Intervention