BD PHASEAL? PROTECTOR P14J 515109

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 2020-03-10 for BD PHASEAL? PROTECTOR P14J 515109 manufactured by Becton Dickinson, S.a..

MAUDE Entry Details

Report Number3003152976-2020-00111
MDR Report Key9812193
Report SourceFOREIGN,OTHER,USER FACILITY
Date Received2020-03-10
Date of Report2020-02-20
Date of Event2020-02-01
Date Mfgr Received2020-02-19
Device Manufacturer Date2019-07-12
Date Added to Maude2020-03-10
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? PROTECTOR P14J
Generic NamePROTECTOR
Product CodeONB
Date Received2020-03-10
Catalog Number515109
Lot Number1907106
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 2020-03-10

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