MAUDE Adverse Event Report: INTEGRA - PRINCETON DURASEAL DURAL SEALANT SYSTEM 5ML US BOX OF 5; DURASEAL CRANIAL

Catalog Number	202050
Medical Device Problem Code	Improper Chemical Reaction (2952)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/17/2025
Type of Reportable Event	Malfunction
Event or Problem Description
A facility reported that during a procedure (tumor dura) with duraseal dural sealant system 5ml (202050), the diluent syringe could not turn into hydrogel formation.The product was in contact with the patient when this occurred.However, there was no patient injury or surgical delay.
Additional Manufacturer Narrative
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
Duraseal dural sealant system (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 1 open pouch, 1 open tray, 3 spray tips, 1 y-connector, 2 holders, 1 borate syringe with its white cap, 1 phosphate syringe with its blue cap, and 1 vial.Spray tips, y-connector, and holders were visually inspected and there were no signs of use or damages detected.The clear syringe was observed empty and fully depressed, the white cap was removed, and no evidence of a blue solution was detected in the component nor damages in both.The blue syringe was observed full of 2.5ml of solution.The blue cap was removed, and no damage was detected in the tip or luer lock connection of the syringe.The vial was observed with the spike fully depressed; the red line indicator was not visible.No traces of blue solution were present on top of the spike.The blue solution inside of the vial was still fluid as well.With the sample evaluated, it was observed that the correct solution was not used to get the reconstitution of the peg and the final process was not followed as stated in the ifu.To get reconstitution, the peg must be mixed with the phosphate solution (blue syringe) instead of the borate solution and the phosphate solution was observed full of solution.As a result, the final assembly was not performed.As a part of sample evaluation, the final assembly was performed, and it was not possible to get the hydrogel.Therefore, the failure mode could be confirmed.Root cause: product received was tested and the failure mode reported was confirmed, and the root cause is undetermined because as part of sample evaluation, the final assembly was performed, and it was not possible to get the hydrogel.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.
Event or Problem Description
N/a.

• Brand Name: DURASEAL DURAL SEALANT SYSTEM 5ML US BOX OF 5
• Common Device Name: DURASEAL CRANIAL
• Manufacturer (Section D): INTEGRA - PRINCETON; 1100 campus road; 1100 campus road; princeton NJ 08540
• Manufacturer (Section G): INTEGRA - PRINCETON; 1100 campus road; none; princeton NJ 08540
• Manufacturer Contact: vivian nelson ; 1100 campus drive; princeton, NJ 08540 ; 6099362319
• MDR Report Key: 22027158
• Report Number: 3003418325-2025-00018
• Device Sequence Number: 9390214
• Product Code: NQR
• UDI-Device Identifier: 10381780000020
• UDI-Public: 10381780000020
• Combination Product (Y/N): N
• PMA/510(K) Number: P040034
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/20/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 202050
• Device Lot Number: 60516358
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/21/2025
• Supplement Date Received by Manufacturer: 05/30/2025
• Initial Report FDA Received Date: 05/15/2025
• Supplement Report FDA Received Date: 06/20/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/01/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown