MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2007-11-21 for COAGUCHECK CAPILLARY BLOOD COLLECTION SYSTEM 11621173001 manufactured by Roche Diagnostics.
[776197]
Caller states that blood was drawn into a coaguchek capillary tube prior to the bulb being placed on the end. As a result, blood from the capillary tube was transferred to the nurse and entered the nurse's eye. The eye was irrigated and the nurse was given travata pending lab results. Labeling advises to place bulb on end of capillary tube prior to blood collection.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1823260-2007-10157 |
| MDR Report Key | 955046 |
| Report Source | 05 |
| Date Received | 2007-11-21 |
| Date of Report | 2007-11-21 |
| Date of Event | 2007-11-14 |
| Date Mfgr Received | 2007-11-15 |
| Date Added to Maude | 2007-12-04 |
| 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 | 0 |
| Event Location | 3 |
| Manufacturer Contact | SALLY BOWDEN |
| Manufacturer Street | 9115 HAGUE RD. |
| Manufacturer City | INDIANAPOLIS IN 46250 |
| Manufacturer Country | US |
| Manufacturer Postal | 46250 |
| Manufacturer Phone | 3175214668 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | COAGUCHECK CAPILLARY BLOOD COLLECTION SYSTEM |
| Generic Name | CAPILLARY TUBE - GIO |
| Product Code | GIO |
| Date Received | 2007-11-21 |
| Catalog Number | 11621173001 |
| Lot Number | 60601 |
| Device Expiration Date | 2012-12-31 |
| Operator | OTHER |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | N |
| Implant Flag | N |
| Date Removed | B |
| Device Sequence No | 1 |
| Device Event Key | 927425 |
| Manufacturer | ROCHE DIAGNOSTICS |
| Manufacturer Address | INDIANAPOLIS IN US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2007-11-21 |