BD VACUTAINER? BORIC ACID SODIUM BORATE/FORMATE C&S URINE TUBE 364955

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 2020-03-18 for BD VACUTAINER? BORIC ACID SODIUM BORATE/FORMATE C&S URINE TUBE 364955 manufactured by Becton, Dickinson & Co. (broken Bow).

Event Text Entries

[186300592] A device evaluation and/or device history review is anticipated, but is not complete. Upon completion, a supplemental report will be filed.
Patient Sequence No: 1, Text Type: N, H10


[186300593] It was reported that bd vacutainer? Boric acid sodium borate/formate c&s urine tubes were underfilling. The following information was provided by the initial reporter: "low samples draw volume - 1-2 ml out of 10 ml. "
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number1917413-2020-00294
MDR Report Key9850249
Report SourceFOREIGN,OTHER,USER FACILITY
Date Received2020-03-18
Date of Report2020-02-28
Date of Event2020-02-10
Date Mfgr Received2020-02-27
Device Manufacturer Date2019-02-05
Date Added to Maude2020-03-18
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? BORIC ACID SODIUM BORATE/FORMATE C&S URINE TUBE
Generic NameTRANSPORT CULTURE MEDIUM
Product CodeJSL
Date Received2020-03-18
Catalog Number364955
Lot Number9036689
Device AvailabilityN
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 2020-03-18

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