MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 2004-02-19 for NEOTREND-L SENSOR N7004L manufactured by Diametrics Medical, Ltd..
[319179]
The user was unable to insert the neotrend-l sensor into the umbilical artery catheter (uac). Whilst attempting the insertion, the sensor was retracted through the y-piece seal and blood leaked back up inside the sensor. No harm or injury to the pt was reported.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9612233-2004-00003 |
| MDR Report Key | 527206 |
| Report Source | 06 |
| Date Received | 2004-02-19 |
| Date of Report | 2004-01-22 |
| Date of Event | 2004-01-01 |
| Date Mfgr Received | 2004-01-22 |
| Device Manufacturer Date | 2003-05-01 |
| Date Added to Maude | 2004-06-01 |
| 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 | SHORT ST |
| Manufacturer City | HIGH WYCOMBE, BUCKS HP112QH |
| Manufacturer Country | UK |
| Manufacturer Postal | HP11 2QH |
| Manufacturer Phone | 494471671 |
| Manufacturer G1 | DIAMETRICS MEDICAL LTD |
| Manufacturer Street | GEORGE STREET |
| Manufacturer City | HIGH WYCOMBE, BUCKS HP112XJ |
| Manufacturer Country | UK |
| Manufacturer Postal Code | HP11 2XJ |
| Single Use | 3 |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | NEOTREND-L SENSOR |
| Generic Name | BLOOD GAS MONITORING SYSTEM |
| Product Code | CCE |
| Date Received | 2004-02-19 |
| Returned To Mfg | 2004-01-23 |
| Model Number | N7004L |
| Catalog Number | N7004L |
| Lot Number | 896 |
| ID Number | * |
| Device Expiration Date | 2004-10-01 |
| 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 | 516377 |
| Manufacturer | DIAMETRICS MEDICAL, LTD. |
| Manufacturer Address | GEORGE ST. HIGH WYCOMBE, BUCKS. UK HP11 2XJ |
| Baseline Brand Name | NEOTREND-L MULTIPARAMETER SENSOR |
| Baseline Generic Name | NEOTREND |
| Baseline Model No | N7004L |
| Baseline Catalog No | N7004L |
| Baseline ID | NA |
| Baseline Shelf Life Contained | Y |
| Baseline Shelf Life [Months] | 18 |
| Baseline PMA Flag | N |
| Baseline 510K PMN | Y |
| Premarket Notification | K972314 |
| Baseline Preamendment | N |
| Baseline Transitional | N |
| 510k Exempt | N |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2004-02-19 |