BD ULTRA FINE? PEN NEEDLES 2865 320122

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer,other report with the FDA on 2020-03-24 for BD ULTRA FINE? PEN NEEDLES 2865 320122 manufactured by Becton, Dickinson And Co..

MAUDE Entry Details

Report Number9616657-2020-00048
MDR Report Key9876032
Report SourceCONSUMER,OTHER
Date Received2020-03-24
Date of Report2020-04-01
Date of Event2020-03-04
Date Mfgr Received2020-03-04
Device Manufacturer Date2019-09-27
Date Added to Maude2020-03-24
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 CO.
Manufacturer StreetDONORE ROAD
Manufacturer CityDROGHEDA
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameBD ULTRA FINE? PEN NEEDLES
Generic NameHYPODERMIC SINGLE LUMEN NEEDLE
Product CodeFMI
Date Received2020-03-24
Model Number2865
Catalog Number320122
Lot Number9205404
OperatorLAY USER/PATIENT
Device Availability*
Device AgeDA
Device Eval'ed by MfgrY
Device Sequence No1
Device Event Key0
ManufacturerBECTON, DICKINSON AND CO.
Manufacturer AddressDONORE ROAD DROGHEDA


Patients

Patient NumberTreatmentOutcomeDate
101. Other 2020-03-24

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