MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 2004-07-23 for NEOTREND - L SENSOR N7004L manufactured by Diametrics Medical Ltd..
[16139143]
Upon successful calibration, neotrend - l sensor was attached to a dmi 3. 7fr vac and insertion was attempted. The sensor would not extend past the luer lock tip. The clinician left the sensor attached to the vac and momentarily left the bedside. Within seconds upon return, blood was seen on the white cloth covering the pt. Exam of the sensor revealed that blood was moving up the vac, through the sensor and out ot the advancement lock. The sensor was removed and saved for exam. The pt required a blood transfusion as a result of blood lost through sampling for testing purposes and the incident described above. No other intervention was required.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9612233-2004-00016 |
| MDR Report Key | 536914 |
| Report Source | 06 |
| Date Received | 2004-07-23 |
| Date of Report | 2004-06-28 |
| Date of Event | 2004-06-26 |
| Date Mfgr Received | 2004-06-28 |
| Device Manufacturer Date | 2003-12-01 |
| Date Added to Maude | 2004-08-02 |
| 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 | 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 | 2004-07-23 |
| Returned To Mfg | 2004-07-05 |
| Model Number | N7004L |
| Catalog Number | N7004L |
| Lot Number | 910 |
| ID Number | * |
| Device Expiration Date | 2005-05-01 |
| 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 | 526154 |
| 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 | 1. Required No Informationntervention | 2004-07-23 |