MAUDE Adverse Event Report: Integra - Princeton DURASEAL DURAL SEALANT SYSTEM 5ML US BOX OF 5; Dural Repair

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	06/24/2026
Type of Reportable Event	Malfunction
Event or Problem Description
An authorized distributory reported that while duraseal dural sealant system (202050) was in contact with a patient, it could not turn into hydrogel formation.A replacement product was used to complete the procedure.There was no surgical delay or patient injury.
Additional Manufacturer Narrative
The 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 - the returned product was received in used condition within an opened pouch containing an assembled syringe system (blue syringe, clear syringe, plunger cap, syringe holder, y-connector, and spray tip), along with an empty vial with vial adapter and additional spray tips.The assembled product was visually inspected and evidence of mixing was observed, as the blue dye solution was present within the blue syringe, indicating that the vial contents had been transferred into the syringe.However, the y-connector was not attached to the syringe assembly at the time of return.Since the y-connector is required to connect both syringes and facilitate the mixing of the precursor solutions during delivery, gel formation would not have been possible with the assembly in the returned configuration.The blue syringe was visually inspected and found to be empty.However, traces of blue liquid residue were observed within the syringe barrel and at the syringe tip, indicating that liquid had previously been present in the syringe.No other abnormalities were noted during the visual inspection.The clear syringe was visually inspected and found to be empty.Residues of salt were observed at the syringe tip, indicating that the solution had previously been present in the syringe.No signs of damage, deformation, cracks, or other abnormalities were observed during the visual inspection.The vial was inspected and found to be empty with the vial adapter securely attached.Residues of blue dye solution were observed trapped between the vial and vial adapter connection, as well as within the luer connection.No other abnormalities were noted during the visual inspection.The plunger cap and syringe holder were visually inspected and found to be unused and free of damage.No signs of wear, deformation, cracks, discoloration, or other abnormalities were observed.The spray tips were visually inspected and found to be unused and free of damage, and no signs of wear, deformation, cracks, or other defects were observed.The y-connector was visually inspected and showed no evidence of use or damage.No defects or abnormalities were observed.Based on the condition of the returned assembly, it appears that the contents of the vial were transferred into the blue syringe, as evidenced by the presence of blue dye residue within the syringe.Additionally, both syringes were properly installed within the plunger cap and syringe holder.However, the y-connector was not attached to the syringe assembly at the time of return.Since the y-connector is required to connect the syringes and allow the precursor solutions to combine, the absence of this component would have prevented mixing of the solutions and, consequently, gel formation.Therefore, the returned configuration suggests that the lack of y-connector attachment may have contributed to the reported failure of not gel formation.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.Since the y-connector is required to connect the syringes and enable mixing of the solutions, the returned configuration would not have allowed the solutions to combine and form gel.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.

• Brand Name: DURASEAL DURAL SEALANT SYSTEM 5ML US BOX OF 5
• Common Device Name: Dural Repair
• 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 ; +1(609)936-2319
• MDR Report Key: 50934497
• Report Number: 3003418325-2026-00043
• Device Sequence Number: 9509200
• Product Code: NQR
• UDI-Device Identifier: 10381780537175
• UDI-Public: 10381780537175
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: P040034
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Distributor
• Type of Report: Initial
• Report Date (Section B): 09/29/2026

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: 60711823
• Date Returned to Manufacturer: 07/08/2026
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/18/2026
• Initial Report FDA Received Date: 09/29/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/01/2026
• 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
• Patient Sequence Number: 1
• Patient Sex: Unknown