BD PHASEAL? INJECTOR LUER LOCK N35C 515005

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 2020-03-09 for BD PHASEAL? INJECTOR LUER LOCK N35C 515005 manufactured by Becton Dickinson, S.a..

MAUDE Entry Details

Report Number3003152976-2020-00107
MDR Report Key9806529
Report SourceFOREIGN,OTHER,USER FACILITY
Date Received2020-03-09
Date of Report2020-02-20
Date of Event2020-02-17
Date Mfgr Received2020-02-17
Device Manufacturer Date2018-12-28
Date Added to Maude2020-03-09
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, S.A.
Manufacturer StreetCAMINO DE VALDEOLIVIA S/N
Manufacturer CitySAN AGUSTIN DE GUADALIX
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameBD PHASEAL? INJECTOR LUER LOCK N35C
Generic NameINTRAVASCULAR ADMINISTRATION SET
Product CodeONB
Date Received2020-03-09
Model Number515005
Catalog Number515005
Lot Number1812106
Device AvailabilityN
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerBECTON DICKINSON, S.A.
Manufacturer AddressCAMINO DE VALDEOLIVIA S/N SAN AGUSTIN DE GUADALIX


Patients

Patient NumberTreatmentOutcomeDate
101. Other 2020-03-09

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