BD ULTRA FINE? INSULIN PEN NEEDLE 320478

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer,foreign,other report with the FDA on 2020-01-16 for BD ULTRA FINE? INSULIN PEN NEEDLE 320478 manufactured by Becton Dickinson And Co..

MAUDE Entry Details

Report Number9616656-2020-00006
MDR Report Key9598767
Report SourceCONSUMER,FOREIGN,OTHER
Date Received2020-01-16
Date of Report2020-01-08
Date of Event2020-01-04
Date Mfgr Received2020-01-04
Date Added to Maude2020-01-16
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 StreetPOTTERY ROAD
Manufacturer CityDUN LAOGHAIRE CO
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameBD ULTRA FINE? INSULIN PEN NEEDLE
Generic NamePEN NEEDLE
Product CodeNSC
Date Received2020-01-16
Catalog Number320478
Lot NumberSEE H.10
OperatorLAY USER/PATIENT
Device AvailabilityN
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerBECTON DICKINSON AND CO.
Manufacturer AddressPOTTERY ROAD DUN LAOGHAIRE CO


Patients

Patient NumberTreatmentOutcomeDate
101. Other 2020-01-16

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