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

Catalog Number 202050

Device Problem Coagulation in Device or Device Ingredient (1096)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/04/2022

Event Type  malfunction  

Manufacturer Narrative

The duraseal dural sealant system (202050) was returned for evaluation: device history record: dhr review was performed (including raw material lab testing and release), at the time of manufacturing, records from each manufacturing lot are thoroughly reviewed to ensure that products are released meeting all quality release specifications.Failure analysis - integra has performed a thorough review of the reported incident.The sample returned had the following components: 1 polybag with ifu, opened tray, lid and pouch, with components of a polymer kit.The polymer kit returned had the following: 1 activated peg vial , 2 syringes with their caps, 1 y-connector with no usage signs, 3 spray tips with no usage signs, 1 plunger cap and 1 syringe holder.The borate syringe was found unused, with full 2.5ml.The phosphate syringe was found engaged to the bioset spike without any solution, or any traces of blue peg inside of the syringe.The peg vial had the bioset spike fully depressed, no redline visible, with pieces of dry blue clumps of peg inside of the vial.The bioset spike was not damaged.It is not possible to determine at which point the peg clumped or melted (during transportation to the customer, or during transportation back to manufacturing site for investigation), however since the bioset spike was activated, this could explain why the returned sample has peg that is clumped and blue (the peg inside the vial is hygroscopic, as such air and moisture make it clump/melt and turn blue).Water was placed in the phosphate syringe and it was engaged to the bioset spike to inject the water in the vial.The water was able to inject in the vial, then, the vial was mixed until most of the peg stuck in the walls was able to be removed.The water inside was easy to withdraw from vial to the syringe.The spike was removed and no physical damaged was observed on it.There were no leaks, all components looked acceptable per raw material specification.Root cause - the root cause is undetermined at this time, and the reported condition "jellified" was not confirmed in the complaint evaluation.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.Per the fmea, potential causes of failure include: performance, adhesion barrier.The risk remains acceptable per the risk analysis.

Event Description

A facility reported that the diluent syringe of duraseal dural sealant system (202050) became jellied formation during a procedure described as "tumor dura." there was no patient injury and delay in surgery is unknown.

• Brand Name: DURASEAL DURAL SEALANT SYSTEM 5ML US BOX OF 5
• Type of Device: 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 ; 6099362319
• MDR Report Key: 14493311
• MDR Text Key: 292580012
• Report Number: 3003418325-2022-00009
• Device Sequence Number: 1
• Product Code: NQR
• Combination Product (y/n): N
• PMA/PMN Number: P040034
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 05/24/2022

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
• Device Operator: Health Professional
• Device Catalogue Number: 202050
• Device Lot Number: 60267003
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/16/2022
• Initial Date Manufacturer Received: 05/05/2022
• Initial Date FDA Received: 05/25/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/01/2020
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1