MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,user f report with the FDA on 2016-09-20 for NEURAWRAP NERVE PROTECTOR 10MM ID X 4CM LENGTH NW1040 manufactured by Integra Lifesciences Corporation.
[55211905]
Integra completed its internal investigation 16sep2016. The investigation included: method: review of device history records. Review of complaint management database for similar complaints. Results: according to the dhr review, no anomalies were reported during the packaging process of this lot that could be related to the reported condition. Finished goods (fg) lot 1140388 was released on 02/28/14 and its expiration date is 2016-02. A review of the electronic database from 02/06/14 until 08/19/16, found three (3) complaints (including the one being investigated) related to? Expired product? Have been reported in the neurawrap family at integra lifesciences (b)(4) facility. Approximately (b)(4) units of neurawrap products have been shipped for sales purposes since 02/06/14 until 08/19/16, resulting in a complaint occurrence rate of approximately (b)(4). No similar complaints related to? Expired product? Have been reported for this fg lot 1140388. Conclusion: based on information provided on the complaint record and the failure analysis that was made taking into account the retain samples evaluation, the reported incident (expired product) could not be associated (confirmed) to the manufacturing / packaging process performed at integra (b)(4). 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 the handling of the product (product misuse) at the reporting facility.
Patient Sequence No: 1, Text Type: N, H10
[55211906]
It was reported a procedure was completed with the use of an expired product. It is believed the product is still implanted. The hospital staff initially responded the lot number reported was used for a case that occurred in (b)(6) 2016. This information did not match the information contained in the charge sheet that integra had. The hospital materials manager looked up the case they had for the expired product, and no lot number was recorded in their records. She stated she will have to go back to the patient implant record to verify the event (patient procedure details/date and lot used). Any new or additional information related to this event will be reported in a follow up medwatch report.
Patient Sequence No: 1, Text Type: D, B5
[59241320]
Additional information received via phone call and email with current sales rep 3oct2016: the incorrect lot number (lot # 1140388) was miss-transcribed on a duplicate sales order by the sales representative. The hospital has a? Hard consignment? Agreement where replacement product is directly requested by the hospital of customer service. Those records have the correct lot # for the product used in this event, lot# 1150180, which was not expired at the time of implantation. The duplicate sales order was created in error. No expired product was implanted. Integra completed its internal investigation 1nov2016. The investigation included: method: - review of device history records. - review of complaint management database for similar complaints. Results: although the product was not implanted expired as per new information received on october 03, 2016, the manufacturing process of finished good lot 1150180 was reviewed. Finished goods (fg) lot 1150180 was released on 02/11/15 and its expiration date is 2017-01. According to the dhr review, no anomalies were reported during the packaging process of this lot that could be related to the initial reported condition. No patient harm was reported as part of this incident since no expired product was implanted and no additional complaints have been reported for this fg lot 1150180. A review of complaint system is not necessary at this time since according to the additional information received on october 03, 2016 there was no expired device implanted. Conclusion: the root cause is related to the miss-transcribed lot number 1140388 instead of lot number 1150180 on a duplicate sales order by the sales representative at the reporting facility. Based on the additional information provided on the complaint record on october 03, 2016 (no expired product was implanted) and the failure analysis that was made taking into account the retain samples evaluation, the initial reported incident (expired product) could not be associated to the manufacturing / packaging process performed. Complaint unit was labeled in an accurate manner and applicable procedures were followed. The packaged product had several labels that contained the expiration date that are very noticeable by the end user.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1121308-2016-00019 |
| MDR Report Key | 5964990 |
| Report Source | COMPANY REPRESENTATIVE,USER F |
| Date Received | 2016-09-20 |
| Date of Report | 2016-07-12 |
| Date of Event | 2016-06-01 |
| Date Mfgr Received | 2016-11-01 |
| Device Manufacturer Date | 2015-02-11 |
| Date Added to Maude | 2016-09-20 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | USER MARIA LEONARD |
| Manufacturer Street | 311 ENTERPRISE DRIVE |
| Manufacturer City | PLAINSBORO NJ 08536 |
| Manufacturer Country | US |
| Manufacturer Postal | 08536 |
| Manufacturer Phone | 6099362393 |
| Manufacturer G1 | INTEGRA LIFESCIENCES CORPORATION |
| Manufacturer Street | 105 MORGAN LANE |
| Manufacturer City | PLAINSBORO NJ 08536 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 08536 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | NEURAWRAP NERVE PROTECTOR 10MM ID X 4CM LENGTH |
| Generic Name | NEURAWRAP |
| Product Code | JXI |
| Date Received | 2016-09-20 |
| Catalog Number | NW1040 |
| Lot Number | 1150180 |
| Device Expiration Date | 2016-02-28 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | INTEGRA LIFESCIENCES CORPORATION |
| Manufacturer Address | 105 MORGAN LANE 105 MORGAN LANE PLAINSBORO NJ 08536 US 08536 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2016-09-20 |