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

Catalog Number	202050
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/07/2025
Type of Reportable Event	Malfunction
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.
Event or Problem Description
A facility reported that while in contact with a patient, the duraseal dural sealant system (202050) liquid leaks from the upper side edge of the diluent syringe.No patient injury or surgical delay has been reported.
Additional Manufacturer Narrative
Updated fields: d4, d9, g3, g6, h2, h3, h4, h11 the duraseal dural sealant system (202050) was returned for evaluation: device history record (dhr) review - the dhr was reviewed, and no anomalies were found during the manufacturing and packaging process that could be related to the reported condition.Failure analysis - investigation showed that the sample received back included pouch, tray, y-connector, 3 spray tips, vial assembled to the blue syringe, clear syringe, plunger cap, and syringe holder.The spray tips, y-connector, plunger cap, and syringe holder were visually inspected.The spray tips and y-connector had brown spots; however, there was no damages nor signs of use.The plunger cap and syringe hold also had no damages nor signs of use.The clear syringe was full of solution, the white cap was present, and no damages were detected.The blue syringe was observed fully depressed and it was assembled to the vial.The blue syringe was disassembled from the vial and no damages were detected.The vial was observed with spike fully depressed, and the redline was not visible.The vial had traces of blue liquid inside and on the syringe connector.The blue syringe was filled with water and attached to the spike, water flowed through out of the syringe to the vial and vice versa with no issues with the connection nor the presence of leaks.With the sample available for evaluation, the failure mode reported could not be confirmed as the syringe was able to be assembled properly to the spike and there were no leaks present.As such the reported complaint could not be confirmed.Root cause - the reported complaint is not confirmed and the root cause is undetermined as the syringe was able to be assembled properly to the spike and there were no leaks present.Per the fmea, potential causes of failure include: issues with performance.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.
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: 21547871
• Report Number: 3003418325-2025-00009
• Device Sequence Number: 8050156
• Product Code: NQR
• UDI-Device Identifier: 10381780537175
• UDI-Public: 10381780537175
• 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,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/20/2025

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: 60512600
• 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: 02/11/2025
• Supplement Date Received by Manufacturer: 03/13/2025
• Initial Report FDA Received Date: 03/07/2025
• Supplement Report FDA Received Date: 03/20/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/01/2023
• Is the Device Labeled for Single Use? (Y/N): No
• 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