BD SAF-T-INTIMA? IV CATHETER SAFETY SYSTEM 383328

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 2020-03-31 for BD SAF-T-INTIMA? IV CATHETER SAFETY SYSTEM 383328 manufactured by Bd Infusion Therapy Systems Inc. S.a. De C.v..

MAUDE Entry Details

Report Number9610847-2020-00120
MDR Report Key9908162
Report SourceFOREIGN,OTHER,USER FACILITY
Date Received2020-03-31
Date of Report2020-04-03
Date of Event2020-03-11
Date Mfgr Received2020-03-11
Date Added to Maude2020-03-31
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 SAF-T-INTIMA? IV CATHETER SAFETY SYSTEM
Generic NameN/A
Product CodeFOZ
Date Received2020-03-31
Catalog Number383328
Lot NumberSEE H.10
Device AvailabilityN
Device AgeDA
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. Required No Informationntervention 2020-03-31

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