BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CELSITE

    MDR report key: 6197785 · Received December 22, 2016

    Report

    Report Number
    9612452-2016-00049
    Event Type
    Injury
    Date Received
    December 22, 2016
    Date of Event
    November 22, 2016
    Report Date
    December 19, 2016
    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

    NOTE: PRODUCT REFERENCE 4433750 IS NOT CLEARED IN 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 THE 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 JUST AFTER THE CONNECTION RING, IE IN THE PROXIMAL PART OF THE CATHETER. THE DIAMETERS HAVE BEEN MEASURED. ALL THE MEASUREMENTS ARE COMPLIANT WITH THE SPECIFICATIONS. THE CATHETER MATERIAL HAS NOT DETERIORATED. NO VISIBLE MANUFACTURING DEFECT IS DETECTED. CONCLUSION: NO MANUFACTURING DEFECT WAS DETECTED ON THE INVOLVED DEVICE. THE RUPTURE OCCURED AFTER THE PATIENT HAD A BAD FALL. THIS IS AN ISOLATED CASE. ACCORDING TO THE ABOVE MENTIONED INFORMATION AND IN VIEW THE LOCATION OF THE RUPTURE, THE MOST PROBABLE ROOT CAUSE SEEMS TO BE THE SHOCK DURING THE PATIENT'S FALL. AS A VERY RARE INCIDENT, NO CORRECTIVE ACTION IS ENVISAGED.

    Description of Event or Problem · 1

    CATHETER RUPTURED AFTER A PATIENT BAD FALL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    849058 CELSITE ACCESS PORT SYSTEM LJT B .BRAUN MEDICAL SAS 4433750 36906955

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention