MAUDE Adverse Event Report: INTEGRA LIFESCIENCES CORP DURASEAL SPINE OUS 3ML KIT 5KIT/BOX CE APPROVED

Catalog Number 204003

Device Problems Component Missing (2306); Out-Of-Box Failure (2311)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

Event Description

In the moment that the kit was opened to prepare the sealant mixture, the assistant and nurse saw that the blue syringe that should contain the diluent (blue processor) did not contain it.So, the kit was discarded and they used other one.

Manufacturer Narrative

Integra has completed their internal investigation on (b)(4) 2016.The product was not returned for evaluation.A review of the device history records has been performed.This review confirmed that the lot of products was reviewed and released according to qa specifications.A review of historical complaint data displayed no increase in trends.The clinically applied product was not returned for evaluation; therefore, the specific cause for the problem reported could not be identified.

• Brand Name: DURASEAL SPINE OUS 3ML KIT 5KIT/BOX CE APPROVED
• Type of Device: DURASEAL SPINE
• Manufacturer (Section D): INTEGRA LIFESCIENCES CORP; 311 enterprise drive; 311 enterprise drive; plainsboro NJ 08536
• Manufacturer (Section G): INTEGRA LIFESCIENCES CORP; 311 enterprise drive; plainsboro NJ 08536
• Manufacturer Contact: rowena bunuan ; 311 enterprise drive; plainsboro, NJ 08536 ; 6099362393
• MDR Report Key: 5418728
• MDR Text Key: 38411039
• Report Number: 3003418325-2016-00002
• 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: foreign
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 01/19/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/09/2016
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 204003
• Device Lot Number: N4A0852X
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/01/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/01/2014
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1