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 2018-06-06 for BD VACUTAINER? URINE COLLECTION CUP 364941 manufactured by Becton, Dickinson & Co..

Event Text Entries

[110458362] Date of event: unknown. 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 not observed. A review of the manufacturing records was completed for the incident lot and no issues were identified.
Patient Sequence No: 1, Text Type: N, H10


[110458363] It was reported that bd vacutainer? Urine collection cup experienced leakage. No report of serious injury or medical intervention.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number1917413-2018-01952
MDR Report Key7576374
Date Received2018-06-06
Date of Report2018-05-30
Date of Event2016-08-16
Date Mfgr Received2016-08-16
Device Manufacturer Date2015-12-21
Date Added to Maude2018-06-06
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 & CO.
Manufacturer Street150 SOUTH 1ST AVENUE
Manufacturer CityBROKEN BOW NE 68822
Manufacturer CountryUS
Manufacturer Postal Code68822
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 CodeKDW
Date Received2018-06-06
Returned To Mfg2016-08-19
Catalog Number364941
Lot Number5355555
Device Expiration Date2018-01-31
Device AvailabilityR
Device Eval'ed by MfgrY
Device Sequence No1
Device Event Key0
ManufacturerBECTON, DICKINSON & CO.
Manufacturer Address150 SOUTH 1ST AVENUE BROKEN BOW NE 68822 US 68822


Patients

Patient NumberTreatmentOutcomeDate
101. Other 2018-06-06

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