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 2018-06-12 for BD VACUTAINER? Z (NO ADDITIVE) PLUS URINE TUBE 364915 manufactured by Becton, Dickinson And Company (bd).

Event Text Entries

[111165649] (b)(6). Bd had not received samples, but photos were provided by the customer facility for investigation. The photos were evaluated and the customer's indicated failure mode with the incident lot was observed.
Patient Sequence No: 1, Text Type: N, H10


[111165650] It was reported that bd vacutainer? Z (no additive) plus urine tube was missing components. No report of serious injury or medical intervention.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number9617032-2018-01472
MDR Report Key7591796
Date Received2018-06-12
Date of Report2018-05-21
Date of Event2017-04-05
Date Mfgr Received2017-04-05
Device Manufacturer Date2017-03-01
Date Added to Maude2018-06-12
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 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 CodeJSL
Date Received2018-06-12
Catalog Number364915
Lot Number7060588
Device Expiration Date2018-02-28
Device AvailabilityN
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerBECTON, DICKINSON AND COMPANY (BD)
Manufacturer AddressBELLIVER WAY BELLIVER INDUSTRIAL ESTATE PLYMOUTH US


Patients

Patient NumberTreatmentOutcomeDate
101. Other 2018-06-12

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