MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,05,07 report with the FDA on 2012-10-29 for CUVETTE, 5 X 5 X 30 MM 758223 manufactured by Beckman Coulter, Inc..
[2943000]
Bec field service engineer (fse) sustained a minor cut on his finger while he was cleaning the cuvette. The fse reported that the cuvette broke while he was cleaning the cuvette. The fse indicated the cuvette did not break when he removed the cuvette from the reaction wheel of the unicel dxc 800 synchron system. The fse indicated he was wearing appropriate personal protective equipment and used proper cuvette removal tool during the cuvette maintenance. The fse received proper treatment immediately after the injury with necessary vaccinations. Blood test was performed and the results were normal.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2050012-2012-01777 |
| MDR Report Key | 2807607 |
| Report Source | 01,05,07 |
| Date Received | 2012-10-29 |
| Date of Report | 2012-10-03 |
| Date of Event | 2012-09-28 |
| Date Mfgr Received | 2012-10-03 |
| Date Added to Maude | 2012-10-31 |
| 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 | 0 |
| Manufacturer Contact | MS. DUNG NGUYEN |
| Manufacturer Street | 250 S. KRAEMER BLVD. |
| Manufacturer City | BREA CA 92821 |
| Manufacturer Country | US |
| Manufacturer Postal | 92821 |
| Manufacturer Phone | 7149613634 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | CUVETTE, 5 X 5 X 30 MM |
| Generic Name | CONTAINER, SPECIMEN, NON-STERILE |
| Product Code | NNI |
| Date Received | 2012-10-29 |
| Catalog Number | 758223 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BECKMAN COULTER, INC. |
| Manufacturer Address | 250 S. KRAEMER BOULEVARD BREA CA 92821623 US 92821 6232 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2012-10-29 |