MAUDE Adverse Event Report: INTEGRA LIFESCIENCES CORP DURASEAL 5ML 5 KITS/BOX CE APPROVED; DURASEAL CRANIAL

Catalog Number DSD5005

Device Problem Chemical Problem (2893)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/13/2021

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

This is 1 of 3 reports linked to mfg report numbers: 3003418325-2021-00002, 3003418325-2021-00003.A facility reported that duraseal (dsd5005) was thinner than normal.The patient was prepped for surgery and the product was in contact with the patient.There was no delay in surgery, and the case continued as planned using the thinner duraseal and no adverse impact to patient was reported.Additional information has been requested.

Manufacturer Narrative

The duraseal 5ml 5 kits/box ce approved (duraseal) was returned for evaluation: device history record (dhr) - the dhr review and product analysis of the product returned concluded there were no component or assembly component related failures with the returned product or at the time of release.Failure analysis - the returned sample was a finished good box with 4 sealed, complete and unused polymer kits.All kits were reviewed and no issues were found with them, they all met release criteria.All 4 kits were opened, the peg vial activated and the phosphate syringe mixed with the peg powder.Afterwards, the reconstituted peg+phospate were assembled with the y connector +spray tip+borate syringe to form the duraseal gel.No issues with any of the components or with forming of the gel upon shooting and combining per the ifu (instructions for use).The reported condition could not be confirmed.Root cause - product was received for analysis and the investigation could not confirm the complaint reported condition.The root cause is undetermined and was unable to be confirmed in the samples and complaint evaluation.Per the fmea, potential causes of failure include: performance, adhesion barrier.The risk remains acceptable per the risk analysis.

• Brand Name: DURASEAL 5ML 5 KITS/BOX CE APPROVED
• Type of Device: DURASEAL CRANIAL
• Manufacturer (Section D): INTEGRA LIFESCIENCES CORP; 1100 campus drive; 1100 campus drive; princeton NJ 08540
• MDR Report Key: 11341151
• MDR Text Key: 239789191
• Report Number: 3003418325-2021-00001
• 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: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 08/05/2021

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: DSD5005
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/30/2021
• Initial Date Manufacturer Received: 01/27/2021
• Initial Date FDA Received: 02/17/2021
• Supplement Dates Manufacturer Received: 07/22/2021
• Supplement Dates FDA Received: 08/05/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1