MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 99 report with the FDA on 2014-04-23 for EVO-2 200 10641202 manufactured by Tecan Schweiz.
[18933301]
A lab employee was injured reaching into the freedom evo 200 instrument while instrument was running on (b)(6) 2014. The event was reported to tecan on (b)(6) 2014 with a request to re-engage the door locks. The employee received a puncture to his finger from the fixed tip dispensing needles on the liquid handling arm. The finger bled and employee was initially treated by a corporate nurse. An internal safety incident was filed. No add'l info regarding treatment or the seriousness of injury was shared with tecan. The instrument was processing pt samples at the time of the incident. The door locks were disables on the instrument.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1037985-2014-00001 |
| MDR Report Key | 3795499 |
| Report Source | 99 |
| Date Received | 2014-04-23 |
| Date of Report | 2014-04-23 |
| Date of Event | 2014-03-28 |
| Date Facility Aware | 2014-04-02 |
| Report Date | 2014-04-23 |
| Date Reported to FDA | 2014-04-23 |
| Date Reported to Mfgr | 2014-04-02 |
| Date Added to Maude | 2014-05-08 |
| Event Key | 0 |
| Report Source Code | Distributor report |
| Manufacturer Link | N |
| 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 | 3 |
| Event Location | 3 |
| Manufacturer Street | 4022 STIRRUP CREEK RD. |
| Manufacturer City | RESEARCH TRIANGLE PARK NC 27709 |
| Manufacturer Country | US |
| Manufacturer Postal | 27709 |
| Manufacturer G1 | TECAN U.S. |
| Manufacturer Street | 4022 STIRRUP CREEK RD. |
| Manufacturer City | RESEARCH TRIANGLE PARK NC 27709 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 27709 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | EVO-2 200 |
| Generic Name | PIPETTING STATION FOR CLINICAL USE |
| Product Code | JQW |
| Date Received | 2014-04-23 |
| Catalog Number | 10641202 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | 8 YR |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | TECAN SCHWEIZ |
| Manufacturer Address | MAENNEDORF ZUERICH SZ |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2014-04-23 |