MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,08 report with the FDA on 2007-03-28 for PARENCHYMAL BOLT PRESSURE MONITORING KIT * NL950-P manufactured by Integra Neurosciences.
[716228]
The distributor has reported on behalf of the user facility, an "out of box" functional issue with the catheter. It has been further stated that upon opening the package and prior to use, it was observed that the fiberoptic was exposed at the catheter tip. An immediate replacement was provided to the hospital and no patient injury or procedure delay was reported.
Patient Sequence No: 1, Text Type: D, B5
[7854264]
To date, the device involved in the reported incident has not been received for evaluation. An investigation has been initiated based on the initial information.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2023988-2007-00016 |
| MDR Report Key | 921928 |
| Report Source | 01,08 |
| Date Received | 2007-03-28 |
| Date of Report | 2007-03-26 |
| Date of Event | 2007-02-08 |
| Date Mfgr Received | 2007-03-05 |
| Date Added to Maude | 2007-10-03 |
| 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 | 0 |
| Manufacturer Contact | LINDA GOODSTEIN |
| Manufacturer Street | 311C ENTERPRISE DRIVE |
| Manufacturer City | PLAINSBORO NJ 08536 |
| Manufacturer Country | US |
| Manufacturer Postal | 08536 |
| Manufacturer Phone | 6099362269 |
| Manufacturer G1 | INTEGRA NEUROSCIENCES |
| Manufacturer Street | 5955 PACIFIC CENTER BLVD. |
| Manufacturer City | SAN DIEGO CA 92121 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 92121 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | PARENCHYMAL BOLT PRESSURE MONITORING KIT |
| Generic Name | ICP DISPOSABLES |
| Product Code | HCA |
| Date Received | 2007-03-28 |
| Model Number | * |
| Catalog Number | NL950-P |
| Lot Number | WO51367 |
| ID Number | * |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | R |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 894325 |
| Manufacturer | INTEGRA NEUROSCIENCES |
| Manufacturer Address | * SAN DIEGO CA * US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2007-03-28 |