BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DURASEAL DURAL SEALANT SYSTEM 5ML US BOX OF 5

    MDR report key: 24405646 · Received February 20, 2026

    Report

    Report Number
    3003418325-2026-00005
    Event Type
    Malfunction
    Date Received
    February 20, 2026
    Date of Event
    December 26, 2025
    Report Date
    April 10, 2026
    Manufacturer
    INTEGRA - PRINCETON
    Product Code
    NQR
    UDI-DI
    10381780537175
    PMA / PMN Number
    P040034
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    AN INVESTIGATION HAS BEEN INITIATED BASED ON THE REPORTED INFORMATION. UPON COMPLETION OF THE INVESTIGATION, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 0

    UPDATED FIELDS: D4, D9, G3, G6, H2, H3, H4, H6, H11. THE DURASEAL DURAL SEALANT SYSTEM 5ML US BOX OF 5 (202050) WAS NOT RETURNED FOR ANALYSIS AND THE INVESTIGATION COULD NOT CONFIRM THE COMPLAINT. 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. THE ROOT CAUSE IS UNDETERMINED AND WAS UNABLE TO BE CONFIRMED IN THE COMPLAINT EVALUATION. PER THE FMEA, POTENTIAL CAUSES OF FAILURE INCLUDE: SOLUTION MIXING AND COVERAGE. THE RISK REMAINS ACCEPTABLE PER THE RISK ANALYSIS. NO ENHANCEMENTS OR IMPROVEMENTS WERE GENERATED FOR THE REPORTED CONDITION. THE FILE WILL BE CLOSED AS COULD NOT BE RELIABLY DETERMINED. SHOULD NEW INFORMATION BECOME AVAILABLE, THE FILE WILL BE REOPENED, AND THE INVESTIGATION SUMMARY WILL BE AMENDED AS APPROPRIATE. TRENDS WILL BE MONITORED FOR THIS AND SIMILAR ISSUES. AT PRESENT, WE CONSIDER THIS COMPLAINT TO BE CLOSED.

    Additional Manufacturer Narrative · 0

    THE DURASEAL DURAL SEALANT SYSTEM (202050) HAS BEEN 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 TRAY, TYVEK LID, ESTER VIAL ASSEMBLED WITH VENTED VIAL ADAPTER, TWO SPRAY TIPS, WHITE CAP, BLUE CAP, AND AN ASSEMBLY WITH THE FOLLOWING: SPRAY TIP, Y-CONNECTOR, BLUE SYRINGE, CLEAR SYRINGE, SYRINGE HOLDER, AND HOLDER CAP. THE SPRAY TIPS SHOWED NO SIGNS OF USE, HOWEVER ONE SPRAY TIP WAS COVERED WITH BLUE CRUST THAT LOOKED LIKE IT WAS FORMED AFTER A BLUE LIQUID DRIED. THE SYRINGE HOLDER AND HOLDER CAP WERE VISUALLY INSPECTED, NO DAMAGE WAS DETECTED, ONLY SOME SMALL BLUE STAINS REMAINED ON THE BOTTOM SIDE. THE Y-CONNECTOR WAS ASSEMBLED WITH ONE SPRAY TIP, THEY WERE VISUALLY INSPECTED, NO DAMAGE WAS FOUND, ONLY TRACES OF BLUE SOLUTION. THE ESTER VIAL WAS ASSEMBLED WITH THE VENTED VIAL ADAPTER. THERE WERE BLUE CRUSTS ALL AROUND THE VIAL THAT LOOKED LIKE THEY WERE FORMED AFTER A BLUE LIQUID DRIED. THE BLUE SYRINGE HAD LIQUID INSIDE, AND IT WAS FILLED TO ABOUT THE 1ML MARK. NO DAMAGE WAS OBSERVED ON THE TIP AND THE SYRINGE HAS A KOKOKU TIP. THE CLEAR SYRINGE HAD A LIGHT BLUE LIQUID INSIDE, AND IT WAS FILLED TO ABOUT THE 1.5 ML MARK. NO DAMAGE WAS OBSERVED AND THE SYRINGE HAD A KOKOKU TIP. WHEN THE SYRINGE IS FILLED AT THE MANUFACTURING PROCESS, IT IS FILLED WITH A CLEAR LIQUID NOT WITH A LIGHT BLUE LIQUID LIKE THE ONE RECEIVED. THE SAMPLE WAS RECEIVED ASSEMBLED AND IT WAS CONFIRMED THAT THE LIQUID DID NOT TURN INTO GEL. A WATER TEST WAS PERFORMED AND SHOWED NO ISSUES. ROOT CAUSE - AFTER SAMPLE EVALUATION, THE FAILURE MODE IS CONFIRMED; HOWEVER, THE ROOT CAUSE IS UNDETERMINED. PER THE DFMEA, POTENTIAL CAUSES OF FAILURE INCLUDE: ISSUES WITH SOLUTION MIXING AND COVERAGE. THE COMPLAINT WILL BE CLOSED AS COULD NOT BE RELIABLY DETERMINED, AND THE RISK REMAINS ACCEPTABLE PER THE RISK ANALYSIS. TRENDS WILL BE MONITORED FOR THIS AND SIMILAR ISSUES. AT PRESENT, WE CONSIDER THIS COMPLAINT TO BE CLOSED.

    Description of Event or Problem · 0

    AN AUTHORIZED DISTRIBUTOR REPORTED THAT DURING TUMOR DURA SURGERY, DURASEAL DURAL SEALANT SYSTEM 5MLUS BOX OF 5 (202050) COULD NOT TURN INTO HYDROGEL FORMATION WHILE IN CONTACT WITH THE PATIENT. THERE WAS NO PATIENT INJURY OR SURGICAL DELAY. USE FACILITY: (B)(6) HOSPITAL.

    Description of Event or Problem · 0

    N/A.

    Description of Event or Problem · 0

    N/A.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    391937 DURASEAL DURAL SEALANT SYSTEM 5ML US BOX OF 5 DURAL REPAIR NQR INTEGRA - PRINCETON 60652185 10381780537175

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown