BD VACUTAINER? URINE COLLECTION CUP 364941

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,other,user facility report with the FDA on 2020-02-28 for BD VACUTAINER? URINE COLLECTION CUP 364941 manufactured by Becton, Dickinson And Company (bd).

Event Text Entries

[187252672] Date of event: unknown. The date received by manufacturer has been used for this field. 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


[187252673] It was reported before use the bd vacutainer? Urine collection cup had the stopper creep out or loose closure. The following information was provided by the initial reporter: "problem with the closure of the sterile pots, contains many poorly closed or even completely open pots. Some jars have a crooked lid and their sterility is questionable.?
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number9617032-2020-00189
MDR Report Key9771966
Report SourceFOREIGN,OTHER,USER FACILITY
Date Received2020-02-28
Date of Report2020-03-27
Date of Event2020-02-07
Date Mfgr Received2020-02-07
Device Manufacturer Date2019-11-12
Date Added to Maude2020-02-28
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 CountryUK
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameBD VACUTAINER? URINE COLLECTION CUP
Generic NameSPECIMEN TRANSPORT AND STORAGE CONTAINER
Product CodeJTW
Date Received2020-02-28
Catalog Number364941
Lot Number9316968
Device Availability*
Device AgeDA
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerBECTON, DICKINSON AND COMPANY (BD)
Manufacturer AddressBELLIVER WAY BELLIVER INDUSTRIAL ESTATE PLYMOUTH UK


Patients

Patient NumberTreatmentOutcomeDate
101. Other 2020-02-28

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