MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a other,user facility report with the FDA on 2017-10-19 for EMAG? INSTRUMENT 418591 manufactured by Biomerieux Italia.
[89776742]
A customer in the united states notified biom? Rieux that a field service engineer (fse) was exposed to waste fluid from the emag? System (ref. 418591) while performing a troubleshooting step. The fse reported that the system's peri-pump was running non-stop and not allowing the run to start. Therefore, he was troubleshooting the waste float tanks. The fse was removing the tank and pressed the quick release connection. The tubing located at the bottom of waste tank b flung towards him sending waste droplets near and possibly in his right eye. The fse was not wearing protective eyewear at the time of the incident. The emag? Waste fluid does contain hazardous components as well as potentially containing biohazardous material. The fse performed 15 minutes of eye wash at the facility's eye wash station. He then went to an emergency room for treatment. The treatment he received in the emergency room was not specified. A biom? Rieux internal investigation will be initiated.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3002769706-2017-00306 |
| MDR Report Key | 6962999 |
| Report Source | OTHER,USER FACILITY |
| Date Received | 2017-10-19 |
| Date of Report | 2018-01-02 |
| Date Mfgr Received | 2017-12-07 |
| Date Added to Maude | 2017-10-19 |
| 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 | SERVICE PERSONNEL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MRS. ELLEN WELTMER |
| Manufacturer Street | 595 ANGLUM ROAD |
| Manufacturer City | HAZELWOOD MO 63042 |
| Manufacturer Country | US |
| Manufacturer Postal | 63042 |
| Manufacturer Phone | 3147317301 |
| Manufacturer G1 | BIOMERIEUX ITALIA |
| Manufacturer Street | VIA DI CAMPIGLIANO 58 PONTE-A EMA |
| Manufacturer City | FIRENZE, ITALY 50012 |
| Manufacturer Country | IT |
| Manufacturer Postal Code | 50012 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | EMAG? INSTRUMENT |
| Generic Name | EMAG? |
| Product Code | JJH |
| Date Received | 2017-10-19 |
| Model Number | 418591 |
| Operator | SERVICE PERSONNEL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BIOMERIEUX ITALIA |
| Manufacturer Address | VIA DI CAMPIGLIANO 58 PONTE-A EMA FIRENZE, ITALY 50012 IT 50012 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2017-10-19 |