BD FACSARIA? III 648282D1

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,other,user facility report with the FDA on 2020-03-17 for BD FACSARIA? III 648282D1 manufactured by Becton, Dickinson And Company, Bd Biosciences.

MAUDE Entry Details

Report Number2916837-2020-00002
MDR Report Key9844743
Report SourceFOREIGN,OTHER,USER FACILITY
Date Received2020-03-17
Date of Report2020-03-05
Date of Event2020-03-04
Date Mfgr Received2020-03-05
Device Manufacturer Date2016-12-22
Date Added to Maude2020-03-17
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Reporter OccupationOTHER HEALTH CARE PROFESSIONAL
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Manufacturer ContactBDX BRETT WILKO
Manufacturer Street9450 SOUTH STATE STREET
Manufacturer CitySANDY UT 84070
Manufacturer CountryUS
Manufacturer Postal84070
Manufacturer Phone8015652341
Manufacturer G1BECTON, DICKINSON AND COMPANY, BD BIOSCIENCES
Manufacturer Street2350 QUME DRIVE
Manufacturer CitySAN JOSE CA 95131
Manufacturer CountryUS
Manufacturer Postal Code95131
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameBD FACSARIA? III
Generic NameFLOW CYTOMETER
Product CodeOYE
Date Received2020-03-17
Catalog Number648282D1
Device AvailabilityN
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerBECTON, DICKINSON AND COMPANY, BD BIOSCIENCES
Manufacturer Address2350 QUME DRIVE SAN JOSE CA 95131 US 95131


Patients

Patient NumberTreatmentOutcomeDate
101. Other 2020-03-17

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