MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-03-28 for FACSARIA? FUSION 6B/3R/3V ACDU W/HOOD 656700G2 manufactured by Becton, Dickinson And Company, Bd Biosciences.
[140285046]
The facsaria? Fusion is a product intended for research use only and this report is filed out of an abundance of caution due to serious injury. (b)(6). Device evaluated by mfr: a device evaluation is anticipated, but has not yet begun. Upon completion of the investigation, a supplemental report will be filed.
Patient Sequence No: 1, Text Type: N, H10
[140285047]
It was reported that while using a facsaria? Fusion 6b/3r/3v acdu w/hood (a research use only, ruo, device) the lab technician attempted to change the fluid line from the 70% ethanol tank. The lab technician noted that the outside of the filter was wet. While the lab technician was holding the filter, the filter cap came loose and fluid from the 70% ethanol filter sprayed into the lab technician's face getting into their eyes. The lab technician washed their head and eyes with running water and wiped away the fluid. The lab technician sought medical attention form a physician in the department of internal medicine. The physician gave the lab technician a medical evaluation and assessed the condition of their eyes. The lab technician received further examination at the hospital's eye clinic which confirmed there was no abnormality or scarring in the patient's eyes.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2916837-2019-00107 |
| MDR Report Key | 8460491 |
| Date Received | 2019-03-28 |
| Date of Report | 2019-04-16 |
| Date of Event | 2019-02-25 |
| Date Mfgr Received | 2019-02-27 |
| Device Manufacturer Date | 2015-04-29 |
| Date Added to Maude | 2019-03-28 |
| 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 | 3 |
| Event Location | 3 |
| Manufacturer Contact | BDX BRETT WILKO |
| Manufacturer Street | 9450 SOUTH STATE STREET |
| Manufacturer City | SANDY UT 84070 |
| Manufacturer Country | US |
| Manufacturer Postal | 84070 |
| Manufacturer Phone | 8015652341 |
| Manufacturer G1 | BECTON, DICKINSON AND COMPANY, BD BIOSCIENCES |
| Manufacturer Street | 2350 QUME DRIVE |
| Manufacturer City | SAN JOSE CA 95131 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 95131 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | FACSARIA? FUSION 6B/3R/3V ACDU W/HOOD |
| Generic Name | FLOW CYTOMETER |
| Product Code | OYE |
| Date Received | 2019-03-28 |
| Catalog Number | 656700G2 |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BECTON, DICKINSON AND COMPANY, BD BIOSCIENCES |
| Manufacturer Address | 2350 QUME DRIVE SAN JOSE CA 95131 US 95131 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2019-03-28 |