BD VACUTAINER? C&S PRESERVATIVE URINE TUBE 364951

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-08-20 for BD VACUTAINER? C&S PRESERVATIVE URINE TUBE 364951 manufactured by Becton, Dickinson & Co..

Event Text Entries

[117706285] 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


[117706286] It was reported that during use of the bd vacutainer? C&s preservative urine tube, that they are not filling properly when pulling from the foley catheter. There was no report of injury or further medical intervention.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number1917413-2018-03288
MDR Report Key7798829
Date Received2018-08-20
Date of Report2018-10-12
Date of Event2018-08-01
Date Mfgr Received2018-08-02
Device Manufacturer Date2017-11-01
Date Added to Maude2018-08-20
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
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 Phone8015652845
Manufacturer G1BECTON, DICKINSON & CO.
Manufacturer Street150 SOUTH 1ST AVENUE
Manufacturer CityBROKEN BOW NE 68822
Manufacturer CountryUS
Manufacturer Postal Code68822
Single Use3
Previous Use Code3
Event Type3
Type of Report0

Device Details

Brand NameBD VACUTAINER? C&S PRESERVATIVE URINE TUBE
Generic NameTRANSPORT CULTURE MEDIUM
Product CodeJTW
Date Received2018-08-20
Returned To Mfg2018-08-10
Catalog Number364951
Lot Number7305995
Device AvailabilityR
Device AgeDA
Device Eval'ed by MfgrY
Device Sequence No1
Device Event Key0
ManufacturerBECTON, DICKINSON & CO.
Manufacturer Address150 SOUTH 1ST AVENUE BROKEN BOW NE 68822 US 68822


Patients

Patient NumberTreatmentOutcomeDate
101. Other 2018-08-20

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