MAUDE Adverse Event Report: INTEGRA LIFESCIENCES CORPORATION NEURAGEN NERVE GUIDE 6MM ID X 3CM LENGTH

Catalog Number PNG630

Device Problems Device Expiration Issue (1216); Device Handling Problem (3265)

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

Event Date 12/16/2016

Event Type  Injury  

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 that an expired product was implanted on a (b)(6) female.Patient was not injured and no adverse effects has been reported.The device will remain implanted.Patient is aware of the expired product.

Manufacturer Narrative

Integra has completed their internal investigation on january 20, 2017.The investigation included: methods: review of device history records.Review of complaints history.Results: the unit will not be returned since it was implanted in the patient.Dhr review; ten (10) retain sample units were visually inspected for product and packaging appearance, including labeling.No anomalies were observed.All units met product and packaging specifications according to ¿packaged collagen product inspection¿.Complaints history; no similar complaints related to ¿expired product implanted¿ have been reported for this fg lot 1140945.Approximately (b)(4) units of neuragen products have been shipped for sales purposes since december 2014 until december 2016, resulting in a complaint occurrence rate of approximately(b)(4).Conclusion: (root/cause) the reported incident (expired product implanted) could not be associated to the manufacturing / packaging process performed.Complaint unit was labeled in an accurate manner and applicable procedures.The packaged product had several labels that contained the expiration date that are very noticeable by the end user, therefore the reported incident could be associated to inappropriate handling of the product (product misuse) by the reporting facility.

• Brand Name: NEURAGEN NERVE GUIDE 6MM ID X 3CM LENGTH
• Type of Device: NEURAGEN
• Manufacturer (Section D): INTEGRA LIFESCIENCES CORPORATION; 105 morgan lane; 105 morgan lane; plainsboro NJ 08536
• Manufacturer (Section G): INTEGRA LIFESCIENCES CORPORATION; 105 morgan lane; plainsboro NJ 08536
• Manufacturer Contact: sonia irizarry ; 311 enterprise drive; plainsboro, NJ 08536 ; 6099362393
• MDR Report Key: 6224882
• MDR Text Key: 63951143
• Report Number: 1121308-2016-00023
• 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
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 12/19/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/05/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 03/01/2016
• Device Catalogue Number: PNG630
• Device Lot Number: 1140945
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/20/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/31/2014
• 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
• Patient Outcome(s): Other
• Patient Age: 74 YR