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

Catalog Number 202050

Device Problem Contamination /Decontamination Problem (2895)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/25/2020

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

A regulatory affairs staff reported a contamination issue of the 202050 duraseal dural sealant system caused by user error when connecting during a head trauma surgery.The device was not in contact with the patient and there was no delay in surgery.

Event Description

N/a.

Manufacturer Narrative

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 received back had all the accessories with no usage signs, no particulate matter or any other form of contamination.Syringes were received with full 2.5ml.The bioset cap pressed down with no red mark showing in the vial (as indicated in the ifu).The peg inside the vial looks melted/solid and stuck to the side of the vial wall.This condition is expected given the peg powder is sensitive to temp, air and humidity, and the bioset spike on the vial was activated.As such there was air and humidity that entered the vial during transit back to the facility for review of the sample.No issues with any of the components received back that could indicate why the customer experienced the reported condition.It is determined that given the description of the complaint, and the sample received back: contamination caused by user error when connecting, the complaint will be closed as unconfirmed contamination, and root cause is determined to be user error.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 LIFESCIENCES CORP; 1000 campus drive; 1000 campus drive; princeton NJ 08536
• MDR Report Key: 10696337
• MDR Text Key: 214801302
• Report Number: 3003418325-2020-00018
• 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: 09/28/2020

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: 202050
• Device Lot Number: 602155148
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/05/2020
• Initial Date Manufacturer Received: 09/28/2020
• Initial Date FDA Received: 10/19/2020
• Supplement Dates Manufacturer Received: 11/24/2020
• Supplement Dates FDA Received: 12/09/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1