BD VACUTAINER? URINE ANALYSIS PRESERVATIVE TUBE 364992

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-04-08 for BD VACUTAINER? URINE ANALYSIS PRESERVATIVE TUBE 364992 manufactured by Becton, Dickinson & Co. (broken Bow).

Event Text Entries

[142635758] Date of event: unknown. The date received by manufacturer has been used for this field. Device expiration date: unknown. A device evaluation is anticipated, but has not yet begun. Upon completion of the investigation, a supplemental report will be filed. Device manufacture date: unknown.
Patient Sequence No: 1, Text Type: N, H10


[142635759] It was reported that the bd vacutainer? Urine analysis preservative tube experienced erroneous results. The following information was provided by the customer: material no. : 364992, batch/lot: unknown / not provided. It was reported that the customer is "seeing issues with the preservative tubes and using them for er patients when they are sent immediately and the preservative is not necessary. " customer text: we are currently using the tiger top ua, and grey top with the blue cups. We are looking to see if it is an option for our facility to get a kit with the blue cup (364975), yellow top tube with no additive (364980), and the grey culture tube (364951) in one kit all together. We are seeing issues with the preservative tubes, and using them for er patients when they are sent immediately and the preservative is not necessary.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number1917413-2019-01134
MDR Report Key8492111
Date Received2019-04-08
Date of Report2019-04-23
Date of Event2019-03-22
Date Mfgr Received2019-03-22
Date Added to Maude2019-04-08
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? URINE ANALYSIS PRESERVATIVE TUBE
Generic NameSPECIMEN TRANSPORT AND STORAGE CONTAINER
Product CodeKDT
Date Received2019-04-08
Catalog Number364992
Lot NumberUNKNOWN
Device Availability*
Device AgeDA
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 2019-04-08

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