BD VACUTAINER? K2 EDTA (K2E) 10.8MG BLOOD COLLECTION TUBES 367863

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 2020-01-03 for BD VACUTAINER? K2 EDTA (K2E) 10.8MG BLOOD COLLECTION TUBES 367863 manufactured by Becton, Dickinson & Co. (broken Bow).

Event Text Entries

[188062326] A device evaluation is anticipated, but has not yet begun. Upon completion of the investigation, a supplemental report will be filed.
Patient Sequence No: 1, Text Type: N, H10


[188062327] It was reported that an unspecified number of bd vacutainer? K2 edta (k2e) 10. 8mg blood collection tubes experienced foreign matter contamination which was noted prior to use. The following information was provided by the initial reporter: on (b)(6) 2019, before use, the customer found 1ea tube has fm in it. Suspected contamination.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number1917413-2019-02607
MDR Report Key9547237
Report SourceFOREIGN,OTHER,USER FACILITY
Date Received2020-01-03
Date of Report2019-12-20
Date of Event2019-12-18
Date Mfgr Received2019-12-18
Device Manufacturer Date2019-06-07
Date Added to Maude2020-01-03
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) 10.8MG BLOOD COLLECTION TUBES
Generic NameBLOOD SPECIMEN COLLECTION DEVICE
Product CodeGIM
Date Received2020-01-03
Catalog Number367863
Lot Number9158910
Device Availability*
Device Eval'ed by MfgrR
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 2020-01-03

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