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

Catalog Number 202050

Device Problem Manufacturing, Packaging or Shipping Problem (2975)

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

Event Date 04/21/2022

Event Type  malfunction  

Manufacturer Narrative

Attempts are being made to obtain additional information.Upon completion of the investigation, a follow-up report will be submitted.

Event Description

A facility reported that a patient was prepped for a "transphenoidal excision of tumor procedure", but it was discovered that the volume of duraseal dural sealant (202050) was not sufficient.There was 15 minutes delay in surgery with no patient injury.

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: the sample received contained: 1 activated vial with blue syringe attached, 2 syringes, 1 y connector, 3 spray tips and 1 syringe holder.The phosphate syringe comes partially depressed; with about 1ml of blue, liquid solution inside.The clear syringe had 2.5ml filled with no traces of usage.The y connector does not have any traces of solution inside.Syringe holder was found without traces of solution.The 3 spray tips were also found with no usage signs.Bioset red indicator was not visible indicating the spike was fully depressed.The vial had gelled peg inside.Water was placed into phosphate syringe and was engaged to the vial to test injection thru the fluid pathway.The water was able to inject in the vial; as well as, withdraw from the vial into the syringe with no issues.Then, the phosphate syringe was engaged to the y connector in conjunction with the clear syringe to inject the combined solutions onto a paper.The syringes were able to inject into the paper with no issue.With the sample provided, it was unable to confirm the failure mode reported.Storage and temperature conditions were reviewed according to validated criteria and found no problems during transit and manufacturing.No physical damage was observed in the components that could explain reported condition.Inspection records for the raw materials used in subassemblies of the finished good showed all inspections passed.Dhr review showed product was manufactured within the parameters and controls at time of release.Product in improper storage conditions at customer site could have led to this observed failure mode.Root cause: the root cause is undetermined and complaint is unconfirmed.Per the dfmea, potential causes of failure include: performance, application (gel delivery), performance, solution mixing and coverage.The risk remains acceptable per the risk analysis.Should new information become available, the file will be re-opened and the investigation summary will be amended as appropriate.

Event Description

N/a.

• 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: 15564335
• MDR Text Key: 304612553
• Report Number: 3003418325-2022-00022
• 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
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 12/16/2022

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
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 09/12/2022
• Initial Date FDA Received: 10/07/2022
• Supplement Dates Manufacturer Received: 11/30/2022
• Supplement Dates FDA Received: 12/16/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/01/2022
• 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
• Patient Age: 38 YR
• Patient Sex: Female