MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 2004-06-15 for NEORTREND-L SENSOR N7044L manufactured by Diametrics Medical, Ltd..
[379860]
Unable to insert sensor into unbilical vessel catheter, then noticed blood leaking from sensor advancement lock. No report of injury or harm to the patient has been received.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9612233-2004-00011 |
| MDR Report Key | 596875 |
| Report Source | 06 |
| Date Received | 2004-06-15 |
| Date of Report | 2004-05-18 |
| Date of Event | 2004-05-18 |
| Date Mfgr Received | 2004-05-18 |
| Device Manufacturer Date | 2003-10-01 |
| Date Added to Maude | 2005-05-02 |
| 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 | MISS J. WALTERS |
| Manufacturer Street | GEORGE STREET, HIGH WYCOMBE |
| Manufacturer City | BUCKS HP112XJQ |
| Manufacturer Country | UK |
| Manufacturer Postal | HP11 2XJQH |
| Manufacturer Phone | 494471671 |
| Manufacturer G1 | DIAMETRICS MEDICAL LIMITED |
| Manufacturer Street | SHORT STREET, HIGH WYCOMBE |
| Manufacturer City | BUCKS HP112QH |
| Manufacturer Country | UK |
| Manufacturer Postal Code | HP11 2QH |
| Single Use | 3 |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | NEORTREND-L SENSOR |
| Generic Name | BLOOD GAS MONITORING SYSTEM |
| Product Code | CCE |
| Date Received | 2004-06-15 |
| Returned To Mfg | 2004-05-25 |
| Model Number | N7044L |
| Catalog Number | N7044L |
| Lot Number | 907 |
| ID Number | * |
| Device Expiration Date | 2005-03-01 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | NA |
| Device Eval'ed by Mfgr | Y |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 586703 |
| Manufacturer | DIAMETRICS MEDICAL, LTD. |
| Manufacturer Address | GEORGE STREET HIGH WYCOMBE, BUCKS. UK HP11 2XJ |
| Baseline Brand Name | NEORTREND-L SENSOR |
| Baseline Generic Name | BLOOD GAS MONITORING SYSTEM |
| Baseline Model No | N7044L |
| Baseline Catalog No | N7044L |
| Baseline ID | * |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2004-06-15 |