BD VACUTAINER? Z (NO ADDITIVE) PLUS URINE TUBE 364915

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-05-06 for BD VACUTAINER? Z (NO ADDITIVE) PLUS URINE TUBE 364915 manufactured by Becton, Dickinson And Company (bd).

Event Text Entries

[145114881] (b)(6). A device evaluation is anticipated, but has not yet begun. Upon completion of the investigation and/or device history review, a supplemental report will be filed.
Patient Sequence No: 1, Text Type: N, H10


[145114882] It was reported that after use of the bd vacutainer? Z (no additive) plus urine tube when cap is replaced, it sometimes happens that the cap falls down. There were 50 occurrences. Foreign complaint the following information was provided by the initial reporter, translated from (b)(6) to english: urine tube was opened for collection, then when cap is replaced, it sometimes happens that the cap falls down. Hemogard closure drops off.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number9617032-2019-00558
MDR Report Key8583816
Date Received2019-05-06
Date of Report2019-05-31
Date of Event2019-04-24
Date Mfgr Received2019-04-24
Device Manufacturer Date2019-03-04
Date Added to Maude2019-05-06
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 AND COMPANY (BD)
Manufacturer StreetBELLIVER WAY BELLIVER INDUSTRIAL ESTATE
Manufacturer CityPLYMOUTH
Manufacturer CountryUS
Single Use3
Previous Use Code3
Event Type3
Type of Report0

Device Details

Brand NameBD VACUTAINER? Z (NO ADDITIVE) PLUS URINE TUBE
Generic NameTRANSPORT CULTURE MEDIUM
Product CodeFMH
Date Received2019-05-06
Catalog Number364915
Lot Number9063852
Device Availability*
Device AgeDA
Device Eval'ed by MfgrY
Device Sequence No1
Device Event Key0
ManufacturerBECTON, DICKINSON AND COMPANY (BD)
Manufacturer AddressBELLIVER WAY BELLIVER INDUSTRIAL ESTATE PLYMOUTH US


Patients

Patient NumberTreatmentOutcomeDate
101. Other 2019-05-06

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