BD VACUTAINER? URINALYSIS CONCIAL URINE TUBE NO ADDITIVE 364980

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-03-06 for BD VACUTAINER? URINALYSIS CONCIAL URINE TUBE NO ADDITIVE 364980 manufactured by Becton, Dickinson & Co. (broken Bow).

Event Text Entries

[138499521] Date of event: unknown. The date received by manufacturer has been used for this field. (b)(6). 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


[138499522] It was reported that foreign "spots", similar to the consistency of condensation, were present in 11 of the bd vacutainer? Urinalysis concial urine tubes with no additive, and discovered before use. As reported by the customer, translated from spanish to english, "it presents spots inside like it had any additive, seem to spots of condensation. "
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number1917413-2019-00377
MDR Report Key8396325
Date Received2019-03-06
Date of Report2019-03-27
Date of Event2019-02-19
Date Mfgr Received2019-02-19
Device Manufacturer Date2018-07-06
Date Added to Maude2019-03-06
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 Report0

Device Details

Brand NameBD VACUTAINER? URINALYSIS CONCIAL URINE TUBE NO ADDITIVE
Generic NameSPECIMEN TRANSPORT AND STORAGE CONTAINER
Product CodeKDT
Date Received2019-03-06
Returned To Mfg2019-03-01
Catalog Number364980
Lot Number8187644
Device AvailabilityR
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 2019-03-06

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