MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-08-27 for BC BACTEC PLUS AEROBIC/F CULTURE 8089076(04) 442023 manufactured by Becton Dickinson And Company.
Report Number | MW5089370 |
MDR Report Key | 8939537 |
Date Received | 2019-08-27 |
Date of Report | 2019-08-26 |
Date of Event | 2019-08-23 |
Date Added to Maude | 2019-08-28 |
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 | BC BACTEC PLUS AEROBIC/F CULTURE |
Generic Name | SYSTEM, BLOOD CULTURING |
Product Code | MDB |
Date Received | 2019-08-27 |
Model Number | 8089076(04) |
Catalog Number | 442023 |
Lot Number | 9086832(9 TOTAL LOT NUMBERS) |
Operator | HEALTH PROFESSIONAL |
Device Availability | Y |
Device Eval'ed by Mfgr | I |
Device Sequence No | 1 |
Device Event Key | 0 |
Manufacturer | BECTON DICKINSON AND COMPANY |
Manufacturer Address | SPARKS MD 21152 US 21152 |
Brand Name | BC BACTEC PLUS AEROBIC/F CULTURE |
Generic Name | SYSTEM, BLOOD CULTURING |
Product Code | MDB |
Date Received | 2019-08-27 |
Model Number | 8089076(04) |
Catalog Number | 442023 |
Device Availability | * |
Device Eval'ed by Mfgr | I |
Device Sequence No | 2 |
Device Event Key | 0 |
Manufacturer | BECTON DICKINSON AND COMPANY |
Manufacturer Address | SPARKS MD 21152 US 21152 |
Brand Name | BC BACTEC PLUS AEROBIC/F CULTURE |
Generic Name | SYSTEM, BLOOD CULTURING |
Product Code | MDB |
Date Received | 2019-08-27 |
Model Number | 8089076(04) |
Catalog Number | 442023 |
Device Availability | * |
Device Eval'ed by Mfgr | I |
Device Sequence No | 3 |
Device Event Key | 0 |
Manufacturer | BECTON DICKINSON AND COMPANY |
Manufacturer Address | SPARKS MD 21152 US 21152 |
Brand Name | BC BACTEC PLUS AEROBIC/F CULTURE |
Generic Name | SYSTEM, BLOOD CULTURING |
Product Code | MDB |
Date Received | 2019-08-27 |
Model Number | 8089076(04) |
Catalog Number | 442023 |
Device Availability | * |
Device Eval'ed by Mfgr | I |
Device Sequence No | 4 |
Device Event Key | 0 |
Manufacturer | BECTON DICKINSON AND COMPANY |
Manufacturer Address | SPARKS MD 21152 US 21152 |
Brand Name | BC BACTEC PLUS AEROBIC/F CULTURE |
Generic Name | SYSTEM, BLOOD CULTURING |
Product Code | MDB |
Date Received | 2019-08-27 |
Model Number | 8089076(04) |
Catalog Number | 442023 |
Device Availability | * |
Device Eval'ed by Mfgr | I |
Device Sequence No | 5 |
Device Event Key | 0 |
Manufacturer | BECTON DICKINSON AND COMPANY |
Manufacturer Address | SPARKS MD 21152 US 21152 |
Brand Name | BC BACTEC PLUS AEROBIC/F CULTURE |
Generic Name | SYSTEM, BLOOD CULTURING |
Product Code | MDB |
Date Received | 2019-08-27 |
Model Number | 8089076(04) |
Catalog Number | 442023 |
Device Availability | * |
Device Eval'ed by Mfgr | I |
Device Sequence No | 6 |
Device Event Key | 0 |
Manufacturer | BECTON DICKINSON AND COMPANY |
Manufacturer Address | SPARKS MD 21152 US 21152 |
Brand Name | BC BACTEC PLUS AEROBIC/F CULTURE |
Generic Name | SYSTEM, BLOOD CULTURING |
Product Code | MDB |
Date Received | 2019-08-27 |
Model Number | 8089076(04) |
Catalog Number | 442023 |
Device Availability | * |
Device Eval'ed by Mfgr | I |
Device Sequence No | 7 |
Device Event Key | 0 |
Manufacturer | BECTON DICKINSON AND COMPANY |
Manufacturer Address | SPARKS MD 21152 US 21152 |
Brand Name | BC BACTEC PLUS AEROBIC/F CULTURE |
Generic Name | SYSTEM, BLOOD CULTURING |
Product Code | MDB |
Date Received | 2019-08-27 |
Model Number | 8089076(04) |
Catalog Number | 442023 |
Device Availability | * |
Device Eval'ed by Mfgr | I |
Device Sequence No | 8 |
Device Event Key | 0 |
Manufacturer | BECTON DICKINSON AND COMPANY |
Manufacturer Address | SPARKS MD 21152 US 21152 |
Brand Name | BC BACTEC PLUS AEROBIC/F CULTURE |
Generic Name | SYSTEM, BLOOD CULTURING |
Product Code | MDB |
Date Received | 2019-08-27 |
Model Number | 8089076(04) |
Catalog Number | 442023 |
Device Availability | * |
Device Eval'ed by Mfgr | I |
Device Sequence No | 9 |
Device Event Key | 0 |
Manufacturer | BECTON DICKINSON AND COMPANY |
Manufacturer Address | SPARKS MD 21152 US 21152 |
Patient Number | Treatment | Outcome | Date |
---|---|---|---|
1 | 0 | 1. Other; 2. Required No Informationntervention | 2019-08-27 |