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

Catalog Number 202050

Device Problem Use of Device Problem (1670)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/27/2020

Event Type  malfunction  

Manufacturer Narrative

The device was not yet received by 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 customer reported that the diluent syringe (blue label) of the 202050 duraseal dural sealant system was inadequate.This was used for a dural tumor procedure on (b)(6) 2020.Product was in contact with the patient; however, there was no patient injury and no surgical delay.

Manufacturer Narrative

Duraseal sealant 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.Failure analysis: integra has performed a thorough review of the reported incident.The sample receive back had the bioset cap pressed down with no red mark showing in the vial (as indicated in the ifu).The grommet was correctly perforated by the bioset spike.There were blue residues of reconstituted peg observed inside the vial (liquid state) borate syringe was found unused with 2.5ml and capped.Spray tips and y connector were received without usage signs.Phosphate syringe was found without the cap engaged to the bioset threads with traces of reconstituted dried blue peg.Sample received back was tested by injecting water inside the vial thru the bioset.There were no issues when injecting the water thru the bioset , or when drawing the liquid out.The peg powder was dissolved, however with the sample received it is not possible to determine the amount of liquid received by the customer, or why they experienced the reported issue.Root cause analysis: the investigation was unable to determine a root cause or confirm the reported incident.

• Brand Name: DURASEAL DURAL SEALANT SYSTEM 5ML US BOX OF 5
• Type of Device: DURASEAL CRANIAL
• Manufacturer (Section D): INTEGRA LIFE SCIENCES CORP; 1100 campus drive; 1100 campus drive; princeton NJ 08536
• MDR Report Key: 10600968
• MDR Text Key: 209028550
• Report Number: 3003418325-2020-00016
• 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,distri
• Type of Report: Initial,Followup
• Report Date: 09/01/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/29/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 202050
• Device Lot Number: 60228900
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/10/2020
• Date Manufacturer Received: 11/18/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1