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

Catalog Number 202050

Device Problem Chemical Problem (2893)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/18/2020

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 202050 duraseal dural sealant system 5ml could not turn into hydrogel formation during a tumor dura procedure on (b)(6) 2020.The device was in contact with patient but there was no patient injury reported.There was no delay in surgery.

Manufacturer Narrative

Integra has performed a thorough review of the reported incident.The sample receive back contained a vial, 2 syringes and some accessories in the tray.Spray tips and y-connector are clean without usage signs.Borate syringe has full 2.5ml of solution.Phosphate syringe was empty and attached to the bioset threads with traces of blue liquid solution in the fluid pathway.The vial had 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 was blue peg solution all around the circumference of the vial and the bioset walls, indicating that the solution had spilled out.No traces of peg powder.Upon removal of the syringe from the bioset threads it was noticed that the bioset spike had a crack/fissure along the bioset body that ran the length of the spike.There are traces of blue solution in the crack/fissure of the spike.There was no other damage to the bioset.Water was placed on the returned vial by engaging the phosphate syringe with the bioset threaded spike, water was injected in the vial without issues.However water leaked outside the bioset spike thru the fissure in the bioset.It was not possible to withdraw all the water from the inside of the vail.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 bioset sample with the fissure was sent for review to bioset vendor.Vendor reviewed their process and found no issues with the lot reported, or with the process in general that could explain the found condition.Vendor came back with response that if an excessive force is placed on the bioset spike it can crack like the sample returned from the duraseal customer for this complaint.Incoming material inspection and product release found no issues that could explain why the customer experienced the reported issue.However, if the customer manipulated the product beyond what is stated on the ifu causing a fissure on the bioset, this could explain why the reported issue occurred.The file will be closed as root cause cracked component caused by manipulation.Should new information become available, the file will be re-opened and the investigation summary will be amended as appropriate.

• 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: 10557392
• MDR Text Key: 208742606
• Report Number: 3003418325-2020-00015
• 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: 08/24/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/18/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 202050
• Device Lot Number: 60207924
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/13/2020
• Date Manufacturer Received: 12/01/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1