BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DURASEAL DURAL SEALANT SYSTEM 5ML US BOX OF 5

    MDR report key: 23150416 · Received September 25, 2025

    Report

    Report Number
    3003418325-2025-00056
    Event Type
    Malfunction
    Date Received
    September 25, 2025
    Date of Event
    August 1, 2025
    Report Date
    September 25, 2025
    Manufacturer
    INTEGRA - PRINCETON
    Product Code
    NQR
    PMA / PMN Number
    P040034
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    DURASEAL DURAL SEALANT SYSTEM 5ML US BOX OF 5 (202050) WAS RETURNED FOR EVALUATION: DEVICE HISTORY RECORD (DHR) - A DHR REVIEW, AND TRENDING WERE PERFORMED AS PART OF THE EVALUATION. PROPER FINISHED GOOD TESTING WAS PERFORMED PRIOR TO RELEASE AS INDICATED IN THE DHR. FAILURE ANALYSIS - INVESTIGATION SHOWED THAT THE SAMPLE RECEIVED BACK INCLUDED VIAL WITH BLUE SYRINGE ATTACHED, 3 SPRAY TIPS, 1 CLEAR SYRINGE AND ITS WHITE CAP, Y-CONNECTOR, SYRINGE HOLDER, AND CAP HOLDER. THE THREE SPRAY TIPS, SYRINGE/CAP HOLDERS, AND Y-CONNECTOR WERE VISUALLY INSPECTED AND NO DAMAGE WAS DETECTED ON THEM NOR SIGNS OF USAGE. THE CLEAR SYRINGE WAS OBSERVED FULL OF SOLUTION, AND NO DAMAGES WERE DETECTED. THE BLUE SYRINGE WAS RECEIVED ATTACHED TO THE VIAL AND EMPTY WITHOUT BLUE SOLUTION. THE SPIKE WAS OBSERVED FULLY DEPRESSED IN THE VIAL; THE RED LINE INDICATOR WAS NOT VISIBLE. THE SOLUTION INSIDE OF THE VIAL WAS OBSERVED STILL FLUID. THE SYRINGE WAS UNENGAGED; NO DAMAGES WERE OBSERVED IN THE SYRINGE TIP NOR IN THE TOP OF BIOSET. AS PART OF THE EVALUATION, WATER WAS PLACED IN THE BLUE SYRINGE AND THEN CONNECTED TO THE BIOSET, THE WATER COULD BE INJECTED INSIDE OF THE VIAL AND WITHDRAWN TO THE SYRINGE WITHOUT LEAKS OR ISSUES TO RETURN TO THE SYRINGE. THE REPORTED FAILURE MODE COULD NOT BE CONFIRMED. ROOT CAUSE -THE PRODUCT RECEIVED WAS TESTED AND THE FAILURE MODE REPORTED WAS NOT CONFIRMED; THEREFORE, THE ROOT CAUSE OF THE REPORTED FAILURE IS UNDETERMINED. PER THE DFMEA, POTENTIAL CAUSES OF FAILURE INCLUDE ¿ISSUES WITH SOLUTION MIXING AND COVERAGE.¿ THE RISK REMAINS ACCEPTABLE PER THE RISK ANALYSIS. NO ENHANCEMENTS OR IMPROVEMENTS WERE GENERATED FOR THE REPORTED CONDITION. TRENDS WILL BE MONITORED FOR THIS AND SIMILAR ISSUES. AT PRESENT, WE CONSIDER THIS COMPLAINT TO BE CLOSED.

    Description of Event or Problem · 0

    A DISTRIBUTOR REPORTED THAT DURING TUMOR DURA PROCEDURE, THE DURASEAL DURAL SEALANT SYSTEM 5ML US BOX OF 5 (202050) DILUENT SYRINGE <BLUE LABEL> WAS INADEQUATE. THE PRODUCT WAS IN CONTACT WITH THE PATIENT; HOWEVER, NO INJURY OR SURGICAL DELAY RESULTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    268233 DURASEAL DURAL SEALANT SYSTEM 5ML US BOX OF 5 DURASEAL CRANIAL NQR INTEGRA - PRINCETON 60548845

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown