BD KIT URIN CUP PLC 16X100 10.0 UA YEL 364981

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-09-25 for BD KIT URIN CUP PLC 16X100 10.0 UA YEL 364981 manufactured by Becton, Dickinson & Co. (broken Bow).

MAUDE Entry Details

Report Number1917413-2019-02128
MDR Report Key9119341
Date Received2019-09-25
Date of Report2019-09-11
Date of Event2019-09-10
Date Mfgr Received2019-09-10
Device Manufacturer Date2018-08-01
Date Added to Maude2019-09-25
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 & CO. (BROKEN BOW)
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 KIT URIN CUP PLC 16X100 10.0 UA YEL
Generic NameURINE COLLECTION DEVICE
Product CodeJTW
Date Received2019-09-25
Catalog Number364981
Lot NumberUNKNOWN
OperatorLAY USER/PATIENT
Device AvailabilityN
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerBECTON, DICKINSON & CO. (BROKEN BOW)
Manufacturer Address150 SOUTH 1ST AVENUE BROKEN BOW NE 68822 US 68822


Patients

Patient NumberTreatmentOutcomeDate
101. Other 2019-09-25

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.