MAUDE Adverse Event Report: INTEGRA LIFESCIENCES CORP DURASEAL 5ML 1 KIT/BOX CE APPROVED; DURASEAL CRANIAL

Catalog Number DSD5001

Device Problem Product Quality Problem (1506)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/18/2019

Event Type  malfunction  

Manufacturer Narrative

The device is not expected to be 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 quality coordinator reported on behalf of the customer that the dsd5001 duraseal 5ml 1 kit/box blue precursor was mixed into the powder vial and when it was drawn back, it was noted that the volume available to draw back was only 1.5 milliliter (ml).The date of the incident was on (b)(6) 2019.There was patient contact but there was no patient injury or surgery delay.

Manufacturer Narrative

Integra has performed a thorough review of the reported incident.There was no product received back, as such only a dhr review was conducted.The dhr review concluded there were no assembly component related failures at the time of release.With the information provided a root cause could not be reliably determined.Should new information become available, the file will be re-opened and the investigation will be amended as appropriate.

Event Description

N/a.

Manufacturer Narrative

The device was returned for evaluation therefore the failure analysis integra has performed a thorough review of the reported incident.The visual inspection of the returned photos noted: the first photo depicts the clear and blue syringe attached to the applier.There is fluid in both syringes.There appears to be two and a half ml of clear fluid however the blue side cannot be determined from the angle in which the photo was taken.However the blue side is not full.The second photo depicts the clear and blue syringes at a different angle.The three ml mark is visible on the blue syringe but the other numbers are not.There is fluid in both syringes however the blue side is not full.The dhr review concluded there were no assembly component related failures at the time of release.Our investigation was unable to determine a root cause or establish a relationship between the device and the reported condition.No enhancements or improvements were generated for the reported condition.Based on the evidence available the reported condition of product appearance and insufficient volume was confirmed.Between 05nov2019 and 30jun2020, approximately 2,200 mdrs submitted electronically by integra lifesciences via trackwise, integra's complaint handling system, were not received by cdrh due to a computer system issue.Within this time period, an error with integra's middleware, which facilitates communications between trackwise and the fda system, caused the complaint records to close and indicate we had received an acknowledgement 3 from the fda when we had not.Integra interpreted the acknowledgement as a successful submission; however, subsequent investigation revealed the acknowledgement 3 received was from our middleware and not from the fda (these acknowledgements have been retained as part of the documentation of the mdr).The malfunction was related to the relocation of the trackwise application to a new data center during the transition of integra's corporate headquarters from plainsboro, nj to princeton, nj.Previously, integra had been successfully receiving acknowledgements 1, 2, and 3 from the fda, and our records reflect these acknowledgements, including the date and time stamps.Capa pr (b)(4) and nc 20-011 have been opened by integra to further investigate the nonconformance and develop a corrective action plan.The middleware error has been corrected, and integra has filed mdrs since the correction and verified that the appropriate acknowledgements have been received from the fda.Integra is resubmitting all impacted mdr reports for the time period 05nov2019 through 30jun2020.Integra lifesciences contacted (b)(6) , director of regulatory programs, office of product evaluation and quality and (b)(6) , assistant director, mdr team, office of product evaluation and quality on july 8-9, 2020 to report these issues regarding mdr reports.

• Brand Name: DURASEAL 5ML 1 KIT/BOX CE APPROVED
• Type of Device: DURASEAL CRANIAL
• Manufacturer (Section D): INTEGRA LIFESCIENCES CORP; 311 enterprise drive; 311 enterprise drive; plainsboro NJ 08536
• MDR Report Key: 8432222
• MDR Text Key: 139201150
• Report Number: 3003418325-2019-00005
• 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,Followup
• Report Date: 02/26/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/19/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: DSD5001
• Device Lot Number: N8G0233X
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/07/2019
• Date Manufacturer Received: 12/19/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1