MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-02-23 for NEURAWRAP NERVE PROTECTOR 3MM ID X 2CM LENGTH NW320 manufactured by Integra Lifesciences Corporation.
[39379783]
The device involved in the reported incident is not available for evaluation. An investigation has been initiated based on the reported information.
Patient Sequence No: 1, Text Type: N, H10
[39379784]
It was reported that an expired product was implanted. No patient injury was reported. Request for additional information sent.
Patient Sequence No: 1, Text Type: D, B5
[40759057]
Additional information received on (b)(6) 2016: it was reported that the doctor requested the use of nw320, and the nurse did not observe outdate before opening/use. This is the only lot involved.
Patient Sequence No: 1, Text Type: N, H10
[48659621]
Integra has completed their internal investigation on june 9, 2016. The investigation included: methods: evaluation of actual device. Review of device history records. Review of complaints history. Results: evaluation of returned device; one (1) used package of neurawrap nerve protector 3mm id x 2cm length corresponding to fg lot # 1135110 was reported as the complaint unit. Since the unit was used it was not returned for evaluation. Ten (10) retain sample units were visually inspected for product and packaging appearance. No anomalies were observed. All units met product and packaging specifications. Dhr review; no anomalies were reported during the packaging process of this lot that could be related to the reported condition. Neurawrap nerve protector 3mm id x 2cm length, fg lot # 1135110 was manufactured through the following processes: cutting, inspection, trays cleaning, tyvek lids stamping and inspection, packaging, packaging inspection, bulk boxing, bulk boxing inspection, sterilization, piggyback and outer box labels printing, labels inspection, labels application and boxing, final inspection, and product release processes. Complaints history; approximately (b)(4) units of neurawrap products have been shipped for sales purposes since 2013 until 02/10/16, resulting in a complaint occurrence rate of approximately (b)(4). This was determined by dividing the number of complaints in this category (1) by the number of units shipped for sales purposes of the neurawrap units. 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 (use of expired product) could not be associated to the manufacturing / packaging process performed at integra. Complaint unit was labeled in an accurate manner and applicable procedures. However, during the investigation it was confirmed that as reported by the customer, the integra sales department was responsible for the inventory. Therefore, the reported condition is confirmed taking into account the information received by the integra? S regional sales manager.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3003418325-2016-00004 |
| MDR Report Key | 5454990 |
| Date Received | 2016-02-23 |
| Date of Report | 2016-02-08 |
| Date Mfgr Received | 2016-06-09 |
| Date Added to Maude | 2016-02-23 |
| 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 SONIA IRIZARRY |
| 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 3MM ID X 2CM LENGTH |
| Generic Name | NEURAWRAP |
| Product Code | JXI |
| Date Received | 2016-02-23 |
| Catalog Number | NW320 |
| Lot Number | 1135110 |
| 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 | 2016-02-23 |