MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-10-17 for RNA MEDICAL CVC223, CO-OXIMETER CALIBRATIN VERIFICATION CVC223, LEVEL 5 CVC2235 manufactured by Rna Medical / Bionostics Inc..
[57973246]
A poc coordinator at (b)(6), cut her finger while opening a glass ampoule of rna medical cvc 223, co-oximeter calibration verification control solution.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5065484 |
| MDR Report Key | 6039478 |
| Date Received | 2016-10-17 |
| Date of Report | 2016-10-17 |
| Date of Event | 2016-10-03 |
| Date Added to Maude | 2016-10-19 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| 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 | 3 |
| Event Location | 3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | RNA MEDICAL CVC223, CO-OXIMETER CALIBRATIN VERIFICATION |
| Generic Name | OXIMETER |
| Product Code | JJY |
| Date Received | 2016-10-17 |
| Model Number | CVC223, LEVEL 5 |
| Catalog Number | CVC2235 |
| Lot Number | 65228 |
| Device Expiration Date | 2017-10-31 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | RNA MEDICAL / BIONOSTICS INC. |
| Manufacturer Address | MA US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2016-10-17 |