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 with the FDA on 2018-05-08 for BD VACUTAINER? URINE COLLECTION CUP 364941 manufactured by Becton, Dickinson And Company (bd).

Event Text Entries

[107824440] Date of event: unknown. The date received by manufacturer has been used for this field. Bd received samples from the customer facility for investigation. The samples were evaluated and the customer's indicated failure mode with the incident lot was observed. A review of the manufacturing records was completed for the incident lot and no issues were identified. Bd has initiated a capa to document further investigation and root cause(s) of this product issue.
Patient Sequence No: 1, Text Type: N, H10


[107824441] While using the bd vacutainer? Urine collection cups, it was reported that "half of urine cups are without needles".
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number9617032-2018-01245
MDR Report Key7495760
Date Received2018-05-08
Date of Report2018-05-08
Date of Event2018-03-02
Date Mfgr Received2018-03-02
Device Manufacturer Date2018-01-10
Date Added to Maude2018-05-08
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? URINE COLLECTION CUP
Generic NameSPECIMEN TRANSPORT AND STORAGE CONTAINER
Product CodeLIO
Date Received2018-05-08
Returned To Mfg2018-03-12
Catalog Number364941
Lot Number8010514
Device Expiration Date2019-12-31
Device AvailabilityR
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 2018-05-08

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