BD? FC BEADS 7-COLOR KIT 656867

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a other,user facility report with the FDA on 2019-11-21 for BD? FC BEADS 7-COLOR KIT 656867 manufactured by Becton, Dickinson And Company, Bd Biosciences.

MAUDE Entry Details

Report Number2916837-2019-00110
MDR Report Key9354657
Report SourceOTHER,USER FACILITY
Date Received2019-11-21
Date of Report2019-10-31
Date of Event2019-10-14
Date Mfgr Received2019-10-24
Device Manufacturer Date2019-01-21
Date Added to Maude2019-11-21
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? FC BEADS 7-COLOR KIT
Generic NameFLOW CYTOMETRIC REAGENTS AND ACCESSORIES
Product CodeOYE
Date Received2019-11-21
Catalog Number656867
Lot Number9021747
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 2019-11-21

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