MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-03-13 for BD VERITOR? SYSTEM FOR RAPID DETECTION OF FLU A+B, 30 TESTS 256045 manufactured by Becton, Dickinson & Co..
[102306560]
It was reported that two patients obtained negative results from a bd veritor? System for rapid detection of flu a+b, 30 tests for flu a/b. Medical intervention was required.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1119779-2018-00004 |
| MDR Report Key | 7335705 |
| Date Received | 2018-03-13 |
| Date of Report | 2018-03-01 |
| Date of Event | 2018-02-05 |
| Date Mfgr Received | 2018-02-16 |
| Device Manufacturer Date | 2017-12-28 |
| Date Added to Maude | 2018-03-13 |
| 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 | 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 | 8015652845 |
| Manufacturer G1 | BECTON, DICKINSON & CO. |
| Manufacturer Street | 7 LOVETON CIRCLE |
| Manufacturer City | SPARKS MD 21152 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 21152 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | BD VERITOR? SYSTEM FOR RAPID DETECTION OF FLU A+B, 30 TESTS |
| Generic Name | FLU LAB KIT |
| Product Code | GNX |
| Date Received | 2018-03-13 |
| Catalog Number | 256045 |
| Lot Number | 7362050 |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BECTON, DICKINSON & CO. |
| Manufacturer Address | 7 LOVETON CIRCLE SPARKS MD 21152 US 21152 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2018-03-13 |