MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 00 report with the FDA on 2007-01-30 for COAGUCHEK PRO CAPILLARY BLOOD COLLECTION SYSTEM * 11621173001 manufactured by Roche Diagnostics.
[590302]
Caller states that she was using the capillary tube and blood splattered on her face twice. Caller states this has happened to another employee as well. No adverse event reported. Customer was putting the bulb on after blood was drawn, against labeling.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1823260-2007-01007 |
| MDR Report Key | 823648 |
| Report Source | 00 |
| Date Received | 2007-01-30 |
| Date of Event | 2007-01-01 |
| Date Mfgr Received | 2007-01-17 |
| Date Added to Maude | 2007-03-07 |
| 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 | 3 |
| Manufacturer Contact | FERN DELACROIX |
| Manufacturer Street | 9115 HAGUE ROAD |
| Manufacturer City | INDIANAPOLIS IN 46250 |
| Manufacturer Country | US |
| Manufacturer Postal | 46250 |
| Manufacturer Phone | 3175217494 |
| Manufacturer G1 | DRUMMOND SCIENTIFIC CORPORATION |
| Manufacturer Street | 500 PARKWAY BOX 700 |
| Manufacturer City | * |
| Manufacturer Country | * |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | COAGUCHEK PRO CAPILLARY BLOOD COLLECTION SYSTEM |
| Generic Name | CAPILLARY TUBE - GIO |
| Product Code | GIO |
| Date Received | 2007-01-30 |
| Model Number | * |
| Catalog Number | 11621173001 |
| Lot Number | * |
| ID Number | * |
| Operator | OTHER |
| Device Availability | N |
| Device Eval'ed by Mfgr | N |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 811053 |
| Manufacturer | ROCHE DIAGNOSTICS |
| Manufacturer Address | * INDIANAPOLIS IN * US |
| Baseline Brand Name | COAGUCHEK PRO CAPILLARY BLOOD COLLECTION SYSTEM |
| Baseline Generic Name | BLOOD CAPILLARY TUBES - JPA |
| Baseline Model No | * |
| Baseline Catalog No | 11621173001 |
| Baseline ID | * |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2007-01-30 |