BD VACUTAINER? PLASTIC 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 2018-04-10 for BD VACUTAINER? PLASTIC URINE COLLECTION CUP 364941 manufactured by Becton, Dickinson And Company (bd).

Event Text Entries

[105315070] There were multiple lot numbers reported to be involved. The information for each lot number is as follows: medical device lot #: 7326651, medical device expiration date: 2019-11-30, device manufacture date: 2017-11-22, medical device lot #: 8036911, medical device expiration date: 2020-01-31, device manufacture date: 2018-02-05. (b)(6). A sample is not available for evaluation. However, a no sample investigation and device history record review will be completed. Upon completion of the investigation, a supplemental report will be filed.
Patient Sequence No: 1, Text Type: N, H10


[105315131] It was reported that a bd vacutainer? Plastic urine collection cup leaked during use. There was no report of exposure, injury or medical interventions.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number9617032-2018-00074
MDR Report Key7413313
Date Received2018-04-10
Date of Report2018-04-20
Date of Event2018-03-13
Date Mfgr Received2018-03-22
Date Added to Maude2018-04-10
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? PLASTIC URINE COLLECTION CUP
Generic NameURINE COLLECTION KIT
Product CodeJTW
Date Received2018-04-10
Catalog Number364941
Lot NumberSEE H.10
Device AvailabilityN
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 2018-04-10

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