BD ULTRA-FINE? PEN NEEDLE 320144

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-09-20 for BD ULTRA-FINE? PEN NEEDLE 320144 manufactured by Becton Dickinson And Co..

MAUDE Entry Details

Report Number9616656-2019-00884
MDR Report Key9097930
Date Received2019-09-20
Date of Report2019-09-06
Date of Event2019-09-04
Date Mfgr Received2019-09-04
Date Added to Maude2019-09-20
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 Report0

Device Details

Brand NameBD ULTRA-FINE? PEN NEEDLE
Generic NamePEN NEEDLE
Product CodeNSC
Date Received2019-09-20
Catalog Number320144
Lot NumberSEE H.10
OperatorLAY USER/PATIENT
Device Availability*
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 2019-09-20

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