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

Catalog Number 202050

Device Problems Fluid/Blood Leak (1250); Obstruction of Flow (2423)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/02/2019

Event Type  malfunction  

Manufacturer Narrative

The device was not yet returned to the manufacturer for analysis.The plant investigation is in progress and a supplemental medwatch report will be submitted upon completion of the investigation.

Event Description

A distributor reported on behalf of the customer that the blue liquid of the 202050 duraseal dural sealant system 5ml leaked due to a blocked y connection (205000ds micromyst applicator) on (b)(6) 2019.There was patient contact but there was no patient injury.A five (5) minute delay in surgery was noted.Additional information received on 26nov2019 indicated that the product problem was discovered during an unknown procedure.There was no patient adverse consequence due to the surgery delay reported.The replacement product was available and used.

Manufacturer Narrative

Additional information - d4, d10, g4, g7, h2, h3, h4, h6, h10.The polymer kit returned had 2 syringes attached to 1 micromyst tubing set.The micromyst is not a product manufactured at flex, or place inside the polymer kit by flex.This component is sold as an accessory to the duraseal polymer kits by integra.The micromyst y-connector was found with indentation marks and usage signs, there were no signs of the fluid pathway being blocked.The dhr review and product analysis of the polymer kit concluded there were no assembly component related failures with the returned product or at the time of release.The reported condition was not confirmed, and no root cause could be determined with the returned samples or the information available.No enhancements or improvements were generated for the reported condition.

• Brand Name: DURASEAL DURAL SEALANT SYSTEM 5ML US BOX OF 5
• Type of Device: DURASEAL CRANIAL
• Manufacturer (Section D): INTEGRA LIFESCIENCES CORP; 1000 campus drive; 1000 campus drive; princeton NJ 08536
• MDR Report Key: 10276783
• MDR Text Key: 242434093
• Report Number: 3003418325-2019-00035
• 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: distributor,foreign,user faci
• Type of Report: Initial,Followup
• Report Date: 11/13/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/15/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/31/2020
• Device Catalogue Number: 202050
• Device Lot Number: 60174239
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/16/2019
• Date Manufacturer Received: 02/13/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: 205000DS MICROMYST APPLICATOR.