MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 2006-11-22 for SUBDURAL TUNNELING KIT * NL950-SD manufactured by Integra Neurosciences.
[19034097]
The device has been received. An investigation has been initiated based upon the reported info.
Patient Sequence No: 1, Text Type: N, H10
[19056025]
The user facility reported the following incident: on 8/21/06, while unpacking the device, the neurosurgical or discovered that the proximal end of the pressure transducer was not in the tip protector. The metallic part had pierced the pouch.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2023988-2006-00051 |
| MDR Report Key | 790458 |
| Report Source | 06 |
| Date Received | 2006-11-22 |
| Date of Report | 2006-11-16 |
| Date of Event | 2006-08-21 |
| Date Mfgr Received | 2006-08-28 |
| Date Added to Maude | 2006-12-07 |
| 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 | DANIEL HOLDERMAN |
| Manufacturer Street | 311 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 | SUBDURAL TUNNELING KIT |
| Generic Name | ICP DISPOSABLES |
| Product Code | HCA |
| Date Received | 2006-11-22 |
| Returned To Mfg | 2006-10-25 |
| Model Number | * |
| Catalog Number | NL950-SD |
| Lot Number | W050712 |
| ID Number | * |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | N |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 778127 |
| Manufacturer | INTEGRA NEUROSCIENCES |
| Manufacturer Address | * SAN DIEGO CA * US |
| Baseline Brand Name | SUBDURAL TUNNELING PRESSURE MONITORING KIT |
| Baseline Generic Name | VENTRICULAR CATHETER |
| Baseline Model No | NA |
| Baseline Catalog No | NL950-SD |
| Baseline ID | NA |
| Baseline Device Family | VENTRICULAR CATHETER |
| Baseline Shelf Life Contained | Y |
| Baseline Shelf Life [Months] | 18 |
| Baseline PMA Flag | N |
| Baseline 510K PMN | Y |
| Premarket Notification | K002392 |
| Baseline Preamendment | N |
| Baseline Transitional | N |
| 510k Exempt | N |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2006-11-22 |