BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CELSITE

    MDR report key: 25317323 · Received May 28, 2026

    Report

    Report Number
    9612452-2026-00026
    Event Type
    Injury
    Date Received
    May 28, 2026
    Date of Event
    April 26, 2026
    Report Date
    May 28, 2026
    Manufacturer
    B.BRAUN MEDICAL SAS
    Product Code
    LJT
    UDI-DI
    04038653917594
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TU
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    NOTE: PRODUCT REFERENCE (B)(4) IS NOT CLEARED FOR SALES IN THE USA, BUT IT IS SIMILAR TO THE PRODUCT REFERENCE CLEARED UNDER #510K130576. THE COMPLAINT CONCERNS 1 UNIT OF CELSITE ST305 SM SET SIL 6,5F IV REFERENCE (B)(4) FROM BATCH 9552041. DEVICE HISTORY RECORD BATCH RECORD FILE, NUMBER (B)(4) WAS REVIEWED: THE BATCH WAS MANUFACTURED WITHIN THE SPECIFICATIONS AND NO DISCREPANCY WAS OBSERVED DURING INSPECTION STEPS. NO OTHER SIMILAR COMPLAINT WAS REPORTED ON THIS BATCH RELEASED IN OCTOBER 2025. SUMMARY OF INVESTIGATION NO INVOLVED DEVICE WAS RETURNED FOR INVESTIGATION. HOWEVER, X-RAY PICTURES AND THE COMPLETED FORM "REQUEST FOR INFORMATION - ACCES PORT INCIDENT " WERE TRANSMITTED FOR INVESTIGATION. ANALYSIS OF RECEIVED INFORMATION: THE DEVICE WAS IMPLANTED DURING 1 MONTHS VIA JUGULAR VEIN. THE PORT WAS SUPERFICIALLY IMPLANTED WITH AN APPROXIMATE CATHETER LENGTH OF 20 CM. THE PATIENT RECEIVED DAILY CHEMOTHERAPY THROUGH THE PORT, WITH REGULAR SALINE FLUSHING. X-RAY PICTURE REVIEW: THE FIRST X-RAY SHOWS THE IMPLANTED VENOUS ACCESS PORT WITH CATHETER INSERTED VIA THE RIGHT INTERNAL JUGULAR VEIN AFTER IMPLANTATION. NO MALPOSITION OR COMPLICATION IS SEEN. THE SECOND CHEST XRAY SHOWS THE IMPLANTED VENOUS ACCESS PORT WITH CATHETER RUPTURE. THE DISTAL FRAGMENT HAS MIGRATED FROM ITS EXPECTED POSITION. RAW MATERIAL HISTORICAL REVIEW: THE BATCH RECORDS OF THE CATHETERS INCLUDED IN THE IMPACTED DEVICE KIT WERE VERIFIED: BATCHES ARE COMPLIANT WITH THE DEFINED SPECIFICATIONS AND NO DISCREPANCY LINKED WITH THIS TYPE OF INCIDENT WAS OBSERVED. ALL RAW MATERIALS (TUBE) USED FOR THE MANUFACTURING WERE ALSO COMPLIANT UPON RECEIPT. NO OTHER COMPLAINT ON KITS PRODUCED WITH THE SAME RAW MATERIAL WAS RECEIVED. -MANUFACTURING PROCESS REVIEW: VISUAL INSPECTIONS AND DIMENSIONAL CONTROLS ARE PERFORMED DURING OUR MANUFACTURING PROCESS ON CATHETERS. NOTHING IN OUR MANUFACTURING PROCESS COULD EXPLAIN THE OBSERVED DEFECT. ALL VISUAL INSPECTIONS WERE COMPLIANT. ROOT CAUSE WITHOUT THE COMPLAINT SAMPLE FOR INVESTIGATION, IT IS NOT POSSIBLE TO CONCLUDE ON THE EXACT ROOT CAUSE OF THIS CATHETER RUPTURE AFTER ONE MONTH OF IMPLANTATION. CONCLUSION WE WERE NOT ABLE TO CONCLUDE ON THE ROOT CAUSE OF THIS INCIDENT. HOWEVER, IT IS WORTH NOTING THAT: - NO OTHER COMPLAINT WAS RECEIVED ABOUT THIS FINISHED BATCH. - THE EXAMINATION OF OUR MANUFACTURING PROCESS AND OF ALL THE DOCUMENTATION RELATED TO THE IMPACTED BATCH HAVE NOT REVEALED FAILURE DURING OUR PRODUCTION PROCESS. THIS TYPE OF INCIDENT IS A KNOWN AND WELL DOCUMENTED POTENTIAL ADVERSE EVENT OF THE IMPLANTATION OF ACCESS PORTS. THIS IS A RARE INCIDENT. IF A SAMPLE DO BECOME AVAILABLE, THE COMPLAINT WILL BE REOPENED FOR FURTHER EVALUATION. NO ACTIONS PLAN IS FORESEEN FOR THE MOMENT.

    Description of Event or Problem · 0

    "WHEN DID THE FAILURE OCCUR: DURING THERAPY. REASON OF COMPLAINT: WE RECEIVED AN E-MAIL FROM A DISTRIBUTER ON 29.04.2026 WITH LIMITED INFORMATION ABOUT A CASE REGARDING A RUPTURED CELSITE PORT CATHETER ART. NO: 4433750 AND BATCH NUMBER 9552041. TODAY WE OBTAINED INFORMATION IN WHICH HOSPITAL THE CASE HAPPENED AND OUR SALES REPS ARE VISITING THE HOSPITAL. THE PORT CATHETER WAS IMPLANTED ON (B)(6) 2026 TO A 17 YEARS OLD MALE PATIENT AND RUPTURED ON (B)(6) 2026. THE MIGRATED CATHETER PART WAS WITHDRAWN VIA ANGIOGRAPHY ON (B)(6) 2026." "CORRECTION OF IMPLANTATION DATE: THE IMPLANTATION DATE IS (B)(6).2026."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    231932 CELSITE ACCESS PORT SYSTEM LJT B.BRAUN MEDICAL SAS 4433750 9552041 04038653917594

    Patients

    Seq Age Sex Outcome Treatment
    1 17 YR Male Required Intervention