MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2020-01-23 for BACT/ALERT 410852 manufactured by Biomerieux , Inc..
[176044651]
A positive culture on a stem cell apheresis collection. Positive in the anaerobic bottle- gram positive cocci in pairs eventually identified as streptococcus parasanguinis. A second sample was sent the following day, but this was from a frozen sampling of that collection. It was negative. Patient also had peripheral blood samples sent for culture which were negative.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9621447 |
| MDR Report Key | 9621447 |
| Date Received | 2020-01-23 |
| Date of Report | 2019-12-03 |
| Date of Event | 2019-11-18 |
| Report Date | 2019-12-03 |
| Date Reported to FDA | 2019-12-03 |
| Date Reported to Mfgr | 2020-01-23 |
| Date Added to Maude | 2020-01-23 |
| Event Key | 0 |
| Report Source Code | User Facility 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 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | BACT/ALERT |
| Generic Name | TUBES, VACUUM SAMPLE, WITH ANTICOAGULANT |
| Product Code | GIM |
| Date Received | 2020-01-23 |
| Model Number | 410852 |
| Lot Number | 4053648 |
| Device Availability | N |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BIOMERIEUX , INC. |
| Manufacturer Address | 100 RODOLPHE ST DURHAM NC 27712 US 27712 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-01-23 |