BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CELSITE

    MDR report key: 13993094 · Received April 4, 2022

    Report

    Report Number
    9612452-2022-00013
    Event Type
    Malfunction
    Date Received
    April 4, 2022
    Date of Event
    October 12, 2021
    Report Date
    April 1, 2022
    Manufacturer
    B.BRAUN MEDICAL SAS
    Product Code
    LJT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    PRODUCT REFERENCE 4430893 IS NOT CLEARED FOR SALES IN THE USA, BUT IT IS SIMILAR TO THE PRODUCT REFERENCE 5430893 CLEARED UNDER #510: K130576. BATCH HISTORY REVIEW: THE MANUFACTURING FILE OF BATCH NR 36976394 WAS CHECKED. IT COMPLIES WITH OUR SPECIFICATIONS AND DOES NOT PRESENT ANY DISCREPANCY. NO OTHER SIMILAR COMPLAINT HAS BEEN REPORTED TO US ON THIS BATCH OF ACCESS PORTS RELEASED IN MARCH 2021. INVESTIGATION RESULTS: THE COMPLAINT SAMPLE WAS NOT RETURNED FOR EVALUATION. WE RECEIVED FOR INVESTIGATION 2 PICTURES OF THE EXPLANTED DEVICE AND 2 X-RAY PICTURES. REVIEW OF THE PICTURES OF THE EXPLANTED DEVICE: THESE PICTURES ALLOW TO SEE THAT THE RUPTURE HAPPENED AT ABOUT 4/5 CM FROM THE ACCESS PORT. THE CATHETER RUPTURE FACIES IS IRREGULAR AND ROUGH. REVIEW OF THE X-RAY PICTURES: THESE PICTURES SHOW THAT THE ACCESS PORT WAS PLACED VIA RIGHT JUGULAR VEIN. A PRONOUNCED ANGLE, NEARLY A KINK IS VISIBLE ON THE CATHETER AT THE ENTRANCE IN THE VEIN. THE RUPTURE OCCURED AT THE LEVEL OF THIS ANGLE. THE DISTAL PART MIGRATED TO THE HEART. CONCLUSION: THE AFOREMENTIONED ELEMENTS ALLOW US TO HYPOTHESISE THAT THE CATHETER RUPTURE WAS DUE TO THE PRONOUNCED ANGLE AT THE ENTRANCE OF THE JUGULAR VEIN. THIS ANGLE GENERATED EARLY WEAR LEADING TO THE TOTAL FRACTURE OF THE CATHETER. THE INSTRUCTIONS FOR USE WARN THE PHYSICIANS TO CHECK THE ABSENCE OF KINK OF THE CATHETER. NO CORRECTIVE ACTION IS ENVISAGED FOR THE MOMENT.

    Description of Event or Problem · 0

    THE CATHETER IS BROKEN INSIDE THE BODY. RE-OPERATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    605453 CELSITE ACCESS PORT SYSTEM LJT B.BRAUN MEDICAL SAS 4430893 36976394

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention