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

Catalog Number 202050

Device Problem Device Ingredient or Reagent Problem (2910)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/16/2020

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

It was reported that the 202050 duraseal dural sealant system 5ml had blue solution clots in the channel of the extended tips (205000ds).The product was used for a tumor dura procedure on (b)(6) 2020.There was patient contact but no patient injury reported nor delay in surgery.

Manufacturer Narrative

Duraseal was returned for evaluation.Device history record (dhr) - 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.Integra has performed a thorough review of the reported incident.The sample receive back had the 2 syringes attached to the luer of the micromyst.A total of 3 spray tips were returned without usage signs.No other components were returned.The micromyst is not a component manufactured at flex (vendor for the duraseal polymer kit).From the review of the components received, and the paperwork review, the investigation was unable to determine a root cause or establish a relationship between the device and the reported incident.No enhancements or improvements were generated for the reported condition.The reported condition was not confirmed.The file will be closed as could not be reliable determined.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 LIFESCIENCES CORP; 1000 campus drive; 1000 campus drive; princeton NJ 08536
• MDR Report Key: 10486202
• MDR Text Key: 231466787
• Report Number: 3003418325-2020-00014
• 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: 08/06/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/02/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 09/30/2021
• Device Catalogue Number: 202050
• Device Lot Number: 60228900
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/12/2020
• Date Manufacturer Received: 11/06/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: 205000DS MICROMYST APPLICATOR.