MAUDE Adverse Event Report: INTEGRA NEUROSCIENCES PR NEURAGEN NERVE GUIDE 3MM ID X 2CM LENGTH

Catalog Number PNG320

Device Problem Device Expiration Issue (1216)

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

Event Date 11/26/2017

Event Type  malfunction  

Manufacturer Narrative

The device involved in the reported incident is not available for evaluation.An investigation has been initiated based on the reported information.

Event Description

It was reported by the account manager that a png320 neuragen was used on (b)(6) 2017 and later found out that the product was expired.There was no information provided regarding patient consequences or delay in the surgery.Attempts to obtain additional information was unsuccessful.

Manufacturer Narrative

Investigation completed on 19jan2018.The dhr was not available for review at this moment.No events and/or rework were recorded for the mentioned lot; therefore, it is concluded that the lot complied with all in-process inspections and testing requirements as specified in the manufacturing shop order and related procedures.Evaluation of retain samples showed that all samples had the correct product information.During the manufacturing/packaging processes there are controls and inspections to ensure that all printed components have the correct information.The fg lot was released on 9/9/2015 complying with the product specifications and requirements.No error was found in the manufacturing/packaging process at integra-añasco.The product was used at 27 months (expiry period is 24 months).There are two stability studies (inpr09-055 and ss-nj-2014-0085) which had successful results up to 30 months when stored under ambient temperature and humidity (including sterility).Nonetheless, it is not recommended to use the product beyond the established expiration date.Therefore, the root cause is related to user error because of using an expired product.

• Brand Name: NEURAGEN NERVE GUIDE 3MM ID X 2CM LENGTH
• Type of Device: NEURAGEN
• Manufacturer (Section D): INTEGRA NEUROSCIENCES PR; road 402 north, km 1.2; road 402 north, km 1.2; anasco PR 00610
• MDR Report Key: 7175395
• MDR Text Key: 97857286
• Report Number: 2648988-2018-00001
• Device Sequence Number: 1
• Product Code: JXI
• Combination Product (y/n): N
• PMA/PMN Number: K011168
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 12/12/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/09/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/01/2017
• Device Catalogue Number: PNG320
• Device Lot Number: 1153468
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/19/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1