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

Catalog Number	202050
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/22/2023
Type of Reportable Event	Malfunction
Event or Problem Description
A distributor reported that during an unspecified surgery, duraseal dural sealant system 5ml us box of 5 (202050) was retrieved from cold shelter for use at the completion of the surgery.The surgical consultant who attended the surgery reported that when he put the syringe in the vial, it began to spill over the sides and the product could not be used - "it was like it didn't fit right." it was necessary to open a new one since it was required for the surgery.There was no patient injury or surgical delay.
Additional Manufacturer Narrative
This initial mdr is a correction mdr for mfg report number 1121308-2024-00002 and is meant to supersede that report for the following reason: the mfg report number 1121308-2024-00002 is incorrect as it is not associated with the legal manufacturer of the reported device.Investigation findings: duraseal sealant system (202050) was not returned for analysis after three good faith attempts (gfes) and the investigation could not confirm the complaint.As a result, the root cause of the reported issue could not be determined.However, lot number information has been provided; therefore, device history record (dhr) was reviewed, and no anomalies were found.Per the fmea, potential causes of failure include: performance [swelling], biocompatibility, performance [packaging integrity], sterilization [system], and sterilization.The risk remains acceptable per the risk analysis.If additional relevant information becomes available in the future, this complaint will be reopened, and the respective evaluation performed.Trends will be monitored for this and similar issues.At present, we consider this complaint to be closed.
Additional Manufacturer Narrative
The duraseal dural sealant system (202050) was not returned; therefore, an evaluation of the device could not be performed.However, investigation using an image and 3 videos provided by the customer was performed as follows: failure analysis: picture 1 shows a top view of one open polymer kit with all the components placed inside of the tray.No signs of usage or damage were observed along with another defect that could create the reported failure mode.Picture 2 shows a capture of video 3, and it was observed that the blue label syringe was connected to the vial, however no drops or liquid can be observed as flown out of the devices.Videos 1 and 2 cannot be opened, and the complaint will be re-opened if they are available.With the pictures and video available for evaluation, the failure mode reported cannot be confirmed.Root cause: the root cause is undetermined and was unable to be confirmed in the complaint evaluation.Product was not received for analysis and the investigation utilizing the photo and videos could not confirm the complaint.If additional relevant information becomes available in the future, this complaint will be reopened, and the respective evaluation performed.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
• Manufacturer (Section G): INTEGRA - PRINCETON; 1100 campus road; none; princeton NJ
• Manufacturer Contact: vivian nelson ; 1100 campus drive; princeton, NJ 08540 ; 6099362319
• MDR Report Key: 18692364
• Report Number: 3003418325-2024-00002
• Device Sequence Number: 15221671
• 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,Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 09/27/2024

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: 60425504
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 01/22/2024
• Supplement Date Received by Manufacturer: 09/17/2024
• Initial Report FDA Received Date: 02/12/2024
• Supplement Report FDA Received Date: 09/27/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/01/2023
• 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: Male