BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRUFILL

    MDR report key: 23571984 · Received November 17, 2025

    Report

    Report Number
    3008114965-2025-01291
    Event Type
    Malfunction
    Date Received
    November 17, 2025
    Date of Event
    November 4, 2025
    Report Date
    November 19, 2025
    Manufacturer
    MEDOS INTERNATIONAL SARL
    Product Code
    KGG
    UDI-DI
    10886704029151
    PMA / PMN Number
    P990040
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    MANUFACTURER REF# (B)(4). MISSING INFORMATION FROM THIS REPORT IS IDENTIFIED AS BLANK; THIS INFORMATION WAS NOT PROVIDED IN THE REPORTED EVENT OR AVAILABLE AT THE TIME OF REPORT SUBMISSION. THIS REPORT IS BEING SUBMITTED PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS REPORT MAY BE BASED ON INFORMATION WHICH HAS NOT BEEN INVESTIGATED OR VERIFIED PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY CERENOVUS, OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE PRODUCT, CERENOVUS, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL REPORT, A FOLLOW-UP REPORT WILL BE FILED AS APPROPRIATE.

    Additional Manufacturer Narrative · 0

    MANUFACTURER REF#: (B)(4). UPDATED SECTIONS ON THIS MEDWATCH: B4, G3, G6, H2, H6 AND H11. COMPLAINT CONCLUSION: A HEALTHCARE PROFESSIONAL REPORTED THAT PRIOR TO GETTING ACCESS IN MIDDLE MENINGEAL ARTERY (MMA) EMBOLIZATION, THE PHYSICIAN WENT TO MIX UP TRUFILL N-BCA-1 GRAM KIT (631500, MC4030) TRUFILL NBCA FOR THE PROCEDURE. WHILE HE WAS DRAWING UP THE NBCA FROM THE TUBE, HE NOTICED THAT THE COLOR AND CONSISTENCY WAS OFF FROM NORMAL. AT THIS POINT HE DISCARDED THE ORIGINAL PRODUCT AND OPENED A NEW KIT. THE EVENT DID NOT OCCUR DURING STERILE PROCESSING AND THERE WAS NO PATIENT INVOLVEMENT. ADDITIONAL EVENT INFORMATION RECEIVED ON (B)(6) 2025 AND (B)(6) 2025 INDICATED THAT THE NBCA GLUE WAS DISCOLORED. THE USER NOTICED AS HE WAS DRAWING THE GLUE OUT OF THE TUBE INTO A SYRINGE. IT WAS NEVER MIXED WITH THE OTHER COMPONENTS. IT WAS CONFIRMED THAT THE LIPOIDAL WAS NOT IMPLICATED. SINCE NO DEVICE HAS BEEN RECEIVED FOR ANALYSIS, NO PRODUCT INVESTIGATION CAN BE PERFORMED AND THE REPORTED FAILURE COULD NOT BE EVALUATED. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE MC4030 NUMBER, AND NO NON-CONFORMANCES RELATED TO THE MALFUNCTION WERE IDENTIFIED. WITH THE INFORMATION AVAILABLE AND WITHOUT THE PRODUCT AVAILABLE FOR ANALYSIS, THE REPORTED CUSTOMER COMPLAINT COULD NOT BE CONFIRMED. BASED ON THE MANUFACTURING RECORD EVALUATION, THERE IS NO INDICATION THAT THE EVENT IS RELATED TO THE DEVICE MANUFACTURING PROCESS. THE EXACT CAUSE OF THE EVENT COULD NOT BE DETERMINED. PER THE INSTRUCTIONS FOR USE (IFU), VERIFY THAT THE N-BCA IS A CLEAR AND FREE-FLOWING LIQUID PRIOR TO USE. DISCARD MATERIAL THAT IS THICKENED OR DISCOLORED. AS PART OF THE POST MARKET SURVEILLANCE PROGRAM, INFORMATION FROM THIS COMPLAINT IS TRENDED TO IDENTIFY STATISTICAL SIGNALS FOR CONSIDERATION OF FURTHER CORRECTION ACTION. SINCE THERE WAS NO EVIDENCE TO SUGGEST THE EVENT WAS RELATED TO A MANUFACTURING OR DESIGN ISSUE, NO CORRECTIVE ACTIONS WILL BE TAKEN AT THIS TIME. A SUPPLEMENTAL REPORT WILL BE SUBMITTED IF NEW FACTS ARISE WHICH MATERIALLY ALTER INFORMATION SUBMITTED IN A PREVIOUS MDR REPORT.

    Description of Event or Problem · 0

    A HEALTHCARE PROFESSIONAL REPORTED THAT PRIOR TO GETTING ACCESS IN MIDDLE MENINGEAL ARTERY (MMA) EMBOLIZATION, THE PHYSICIAN WENT TO MIX UP TRUFILL N-BCA-1 GRAM KIT (631500, MC4030) TRUFILL NBCA FOR THE PROCEDURE. WHILE HE WAS DRAWING UP THE NBCA FROM THE TUBE, HE NOTICED THAT THE COLOR AND CONSISTENCY WAS OFF FROM NORMAL. AT THIS POINT HE DISCARDED THE ORIGINAL PRODUCT AND OPENED A NEW KIT. THE EVENT DID NOT OCCUR DURING STERILE PROCESSING AND THERE WAS NO PATIENT INVOLVEMENT. ADDITIONAL EVENT INFORMATION RECEIVED ON 10-NOV-2025 AND 13-NOV-2025 INDICATED THAT THE NBCA GLUE WAS DISCOLORED. THE USER NOTICED AS HE WAS DRAWING THE GLUE OUT OF THE TUBE INTO A SYRINGE. IT WAS NEVER MIXED WITH THE OTHER COMPONENTS. IT WAS CONFIRMED THAT THE LIPOIDAL WAS NOT IMPLICATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    297206 TRUFILL TISSUE ADHESIVE FOR USE IN EMBOLIZATION OF BRAIN ARTERIOVENOUS MALFORMATIONS KGG MEDOS INTERNATIONAL SARL MC4030 10886704029151

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown