MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 07 report with the FDA on 2010-06-14 for DCA SYSTEMS 2000/2000+ manufactured by Bayer Healthcare Llc.
[1542653]
A medical technician was splashed in the eye with hemoglobin a1c reagent and pt sample when she attempted to remove a cartridge using a pair of scissors. The sample was reported to be from a pt with (b)(6). The technician was sent to the emergency room for follow up treatment. The technician was not wearing safety glasses at the time of the event.
Patient Sequence No: 1, Text Type: D, B5
[8618093]
The technician was advised of proper technique for removing cartridges. Operator reference guide advises: "to remove cartridge - hold button down with right hand. With left hand, gently pull tab on cartridge to right to unlock. Pull upward, discarded cartridge to prevent injury and possible contamination to others".
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1217157-2010-00011 |
| MDR Report Key | 1728305 |
| Report Source | 07 |
| Date Received | 2010-06-14 |
| Date of Report | 2010-05-27 |
| Date of Event | 2010-05-27 |
| Device Manufacturer Date | 2007-01-01 |
| Date Added to Maude | 2012-03-15 |
| 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 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | MARK SMITH |
| Manufacturer Street | 2 EDGEWATER DR. |
| Manufacturer City | NORWOOD MA 02062 |
| Manufacturer Country | US |
| Manufacturer Postal | 02062 |
| Manufacturer Phone | 7812693158 |
| Manufacturer G1 | BAYER HEALTHCARE LLC |
| Manufacturer Street | 430 S BEIGER ST. |
| Manufacturer City | MISHAWAKA IN 46544 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 46544 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | DCA SYSTEMS |
| Generic Name | DCA SYSTEMS |
| Product Code | JIR |
| Date Received | 2010-06-14 |
| Model Number | 2000/2000+ |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BAYER HEALTHCARE LLC |
| Manufacturer Address | 430 S BEIGER ST. MISHAWAKA IN 46544 US 46544 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2010-06-14 |