BD VACUTAINER? K2 EDTA (K2E) 5.4MG BLOOD COLLECTION TUBES 367835

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 2019-12-27 for BD VACUTAINER? K2 EDTA (K2E) 5.4MG BLOOD COLLECTION TUBES 367835 manufactured by Becton, Dickinson & Co. (broken Bow).

MAUDE Entry Details

Report Number1917413-2019-02574
MDR Report Key9527783
Report SourceFOREIGN,OTHER,USER FACILITY
Date Received2019-12-27
Date of Report2020-01-16
Date of Event2019-11-22
Date Mfgr Received2019-12-10
Device Manufacturer Date2019-03-06
Date Added to Maude2019-12-27
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 & CO. (BROKEN BOW)
Manufacturer Street150 SOUTH 1ST AVENUE
Manufacturer CityBROKEN BOW NE 68822
Manufacturer CountryUS
Manufacturer Postal Code68822
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameBD VACUTAINER? K2 EDTA (K2E) 5.4MG BLOOD COLLECTION TUBES
Generic NameBLOOD SPECIMEN COLLECTION DEVICE
Product CodeGIM
Date Received2019-12-27
Model Number367835
Catalog Number367835
Lot Number9065779
Device Availability*
Device AgeDA
Device Eval'ed by MfgrY
Device Sequence No1
Device Event Key0
ManufacturerBECTON, DICKINSON & CO. (BROKEN BOW)
Manufacturer Address150 SOUTH 1ST AVENUE BROKEN BOW NE 68822 US 68822


Patients

Patient NumberTreatmentOutcomeDate
101. Other 2019-12-27

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