BD? ANESTHESIA KIT DURASAFE 18X3-1/2 400714

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor,foreign,other report with the FDA on 2020-01-28 for BD? ANESTHESIA KIT DURASAFE 18X3-1/2 400714 manufactured by Bd Infusion Therapy Systems Inc. S.a. De C.v..

MAUDE Entry Details

Report Number9610847-2020-00024
MDR Report Key9639154
Report SourceDISTRIBUTOR,FOREIGN,OTHER
Date Received2020-01-28
Date of Report2020-01-14
Date of Event2019-12-18
Date Mfgr Received2020-01-07
Device Manufacturer Date2019-06-07
Date Added to Maude2020-01-28
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 G1BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V.
Manufacturer StreetPERIFERICO LUIS DONALDO COLOSIO NO. 579
Manufacturer CityNOGALES
Manufacturer CountryMX
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameBD? ANESTHESIA KIT DURASAFE 18X3-1/2
Generic NameANESTHESIA KIT
Product CodeOFQ
Date Received2020-01-28
Catalog Number400714
Lot Number9074790
Device AvailabilityN
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerBD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V.
Manufacturer AddressPERIFERICO LUIS DONALDO COLOSIO NO. 579 NOGALES MX


Patients

Patient NumberTreatmentOutcomeDate
101. Other 2020-01-28

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