MAUDE Adverse Event Report: INTEGRA LIFESCIENCES CORPORATION DURASEAL SPINE OUS 3ML KIT 1KIT/BOX CE APPROVED

Catalog Number 203001

Device Problem Chemical Problem (2893)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/19/2020

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 facility reported that the duraseal spine ous 3ml kit (203001) did not mix.This occurred while product was in contact with the patient; however, there was no patient injury or death.The event led to an increase in time of surgery, but amount of time is unknown.

Event Description

N/a.

Manufacturer Narrative

The duraseal spine (203001) was not returned for analysis; therefore, the investigation could not confirm the complaint.Lot number information has been provided; therefore, manufacturing records were reviewed and found no anomalies.The root cause is undetermined and was unable to be confirmed in the complaint evaluation.If additional relevant information becomes available in the future, this complaint will be reopened, and the respective evaluation performed.Trends will be monitored for this and similar issues.At present, we consider this complaint to be closed.

Event Description

N/a.

Manufacturer Narrative

Updated fields: d9, g3, g6, h2, h3, h4, h6, h10.Duraseal (203001) was returned for evaluation: device history record (dhr) - the dhr was reviewed and no anomalies related to the reported failure was observed.Failure analysis: the investigation did not confirm the reported issue.The sample receive back included a bag with an open folded pouch with the tray and some components: tray had one spray tip, one vial, one y connector, two syringes and the holder, also tray had traces of blue solution.The blue syringe was empty (completely depressed) with usage signs.No damage/broken was observed on the syringe threads.The borate syringe was also empty (completely depressed) with usage signs.No damage/broken was observed on the syringe threads.Y connector and spray tip with usage signs.Traces of blue liquid in both sides of y connector and blue traces in the spray tip.Bioset was received activated, no red line visible, traces of blue solution on top of the bioset, traces of blue liquid were observed inside the vial.Spike was removed, no damage/broken were observed on it, it had blue traces on it, grommet was fully perforated.Components were assembled again, and water was placed in the phosphate syringe, the water was able to inject and withdraw from the vial without any issues.Per sample revision was observed that the peg & phosphate solution were reconstituted since the vial was received with reconstituted blue liquid peg inside.Root cause: the reported condition was not confirmed.Therefore, the root cause is undetermined and was unable to be confirmed in the samples and complaint evaluation.Per the fmea, potential causes of failure include: performance, adhesion barrier.The risk remains acceptable per the risk analysis.

• Brand Name: DURASEAL SPINE OUS 3ML KIT 1KIT/BOX CE APPROVED
• Type of Device: DURASEAL SPINE
• Manufacturer (Section D): INTEGRA LIFESCIENCES CORPORATION; 105 morgan lane; 105 morgan lane; plainsboro NJ 08536
• MDR Report Key: 11045572
• MDR Text Key: 228035914
• Report Number: 3003418325-2020-00023
• Device Sequence Number: 1
• Product Code: NQR
• Combination Product (y/n): N
• PMA/PMN Number: P080013
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign,user faci
• Type of Report: Initial,Followup,Followup
• Report Date: 09/01/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/21/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 203001
• Device Lot Number: 60221412
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/02/2021
• Date Manufacturer Received: 08/23/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1