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 |