BC BACTEC PLUS AEROBIC/F CULTURE 8089076(04) 442023

MAUDE Adverse Event Report

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.

MAUDE Entry Details

Report NumberMW5089370
MDR Report Key8939537
Date Received2019-08-27
Date of Report2019-08-26
Date of Event2019-08-23
Date Added to Maude2019-08-28
Event Key0
Report Source CodeVoluntary report
Manufacturer LinkN
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Single Use3
Previous Use Code3
Event Type3
Type of Report0

Device Sequence Number: 1

Brand NameBC BACTEC PLUS AEROBIC/F CULTURE
Generic NameSYSTEM, BLOOD CULTURING
Product CodeMDB
Date Received2019-08-27
Model Number8089076(04)
Catalog Number442023
Lot Number9086832(9 TOTAL LOT NUMBERS)
OperatorHEALTH PROFESSIONAL
Device AvailabilityY
Device Eval'ed by MfgrI
Device Sequence No1
Device Event Key0
ManufacturerBECTON DICKINSON AND COMPANY
Manufacturer AddressSPARKS MD 21152 US 21152

Device Sequence Number: 2

Brand NameBC BACTEC PLUS AEROBIC/F CULTURE
Generic NameSYSTEM, BLOOD CULTURING
Product CodeMDB
Date Received2019-08-27
Model Number8089076(04)
Catalog Number442023
Device Availability*
Device Eval'ed by MfgrI
Device Sequence No2
Device Event Key0
ManufacturerBECTON DICKINSON AND COMPANY
Manufacturer AddressSPARKS MD 21152 US 21152

Device Sequence Number: 3

Brand NameBC BACTEC PLUS AEROBIC/F CULTURE
Generic NameSYSTEM, BLOOD CULTURING
Product CodeMDB
Date Received2019-08-27
Model Number8089076(04)
Catalog Number442023
Device Availability*
Device Eval'ed by MfgrI
Device Sequence No3
Device Event Key0
ManufacturerBECTON DICKINSON AND COMPANY
Manufacturer AddressSPARKS MD 21152 US 21152

Device Sequence Number: 4

Brand NameBC BACTEC PLUS AEROBIC/F CULTURE
Generic NameSYSTEM, BLOOD CULTURING
Product CodeMDB
Date Received2019-08-27
Model Number8089076(04)
Catalog Number442023
Device Availability*
Device Eval'ed by MfgrI
Device Sequence No4
Device Event Key0
ManufacturerBECTON DICKINSON AND COMPANY
Manufacturer AddressSPARKS MD 21152 US 21152

Device Sequence Number: 5

Brand NameBC BACTEC PLUS AEROBIC/F CULTURE
Generic NameSYSTEM, BLOOD CULTURING
Product CodeMDB
Date Received2019-08-27
Model Number8089076(04)
Catalog Number442023
Device Availability*
Device Eval'ed by MfgrI
Device Sequence No5
Device Event Key0
ManufacturerBECTON DICKINSON AND COMPANY
Manufacturer AddressSPARKS MD 21152 US 21152

Device Sequence Number: 6

Brand NameBC BACTEC PLUS AEROBIC/F CULTURE
Generic NameSYSTEM, BLOOD CULTURING
Product CodeMDB
Date Received2019-08-27
Model Number8089076(04)
Catalog Number442023
Device Availability*
Device Eval'ed by MfgrI
Device Sequence No6
Device Event Key0
ManufacturerBECTON DICKINSON AND COMPANY
Manufacturer AddressSPARKS MD 21152 US 21152

Device Sequence Number: 7

Brand NameBC BACTEC PLUS AEROBIC/F CULTURE
Generic NameSYSTEM, BLOOD CULTURING
Product CodeMDB
Date Received2019-08-27
Model Number8089076(04)
Catalog Number442023
Device Availability*
Device Eval'ed by MfgrI
Device Sequence No7
Device Event Key0
ManufacturerBECTON DICKINSON AND COMPANY
Manufacturer AddressSPARKS MD 21152 US 21152

Device Sequence Number: 8

Brand NameBC BACTEC PLUS AEROBIC/F CULTURE
Generic NameSYSTEM, BLOOD CULTURING
Product CodeMDB
Date Received2019-08-27
Model Number8089076(04)
Catalog Number442023
Device Availability*
Device Eval'ed by MfgrI
Device Sequence No8
Device Event Key0
ManufacturerBECTON DICKINSON AND COMPANY
Manufacturer AddressSPARKS MD 21152 US 21152

Device Sequence Number: 9

Brand NameBC BACTEC PLUS AEROBIC/F CULTURE
Generic NameSYSTEM, BLOOD CULTURING
Product CodeMDB
Date Received2019-08-27
Model Number8089076(04)
Catalog Number442023
Device Availability*
Device Eval'ed by MfgrI
Device Sequence No9
Device Event Key0
ManufacturerBECTON DICKINSON AND COMPANY
Manufacturer AddressSPARKS MD 21152 US 21152


Patients

Patient NumberTreatmentOutcomeDate
101. Other; 2. Required No Informationntervention 2019-08-27

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