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 from a health professional,other,use report with the FDA on 2019-12-27 for BD KIT URIN CUP PLC 16X100 10.0 UA YEL 364981 manufactured by Becton, Dickinson & Co. (broken Bow).

MAUDE Entry Details

• Report Number: 1917413-2019-02577
• MDR Report Key: 9527947
• Report Source: HEALTH PROFESSIONAL,OTHER,USE
• Date Received: 2019-12-27
• Date of Report: 2020-03-25
• Date of Event: 2019-12-10
• Date Mfgr Received: 2019-12-10
• Device Manufacturer Date: 2019-02-27
• Date Added to Maude: 2019-12-27
• Event Key: 0
• Report Source Code: Manufacturer report
• Manufacturer Link: Y
• Number of Patients in Event: 0
• Adverse Event Flag: 3
• Product Problem Flag: 3
• Reprocessed and Reused Flag: 3
• Reporter Occupation: OTHER HEALTH CARE PROFESSIONAL
• Health Professional: 3
• Initial Report to FDA: 3
• Report to FDA: 3
• Event Location: 3
• Manufacturer Contact: BDX BRETT WILKO
• Manufacturer Street: 9450 SOUTH STATE STREET
• Manufacturer City: SANDY UT 84070
• Manufacturer Country: US
• Manufacturer Postal: 84070
• Manufacturer Phone: 8015652341
• Manufacturer G1: BECTON, DICKINSON & CO. (BROKEN BOW)
• Manufacturer Street: 150 SOUTH 1ST AVENUE
• Manufacturer City: BROKEN BOW NE 68822
• Manufacturer Country: US
• Manufacturer Postal Code: 68822
• Single Use: 3
• Previous Use Code: 3
• Event Type: 3
• Type of Report: 3

Device Details

• Brand Name: BD KIT URIN CUP PLC 16X100 10.0 UA YEL
• Generic Name: URINE COLLECTION DEVICE
• Product Code: JTW
• Date Received: 2019-12-27
• Catalog Number: 364981
• Lot Number: 9058550
• Device Availability: *
• Device Age: DA
• Device Eval'ed by Mfgr: R
• Device Sequence No: 1
• Device Event Key: 0
• Manufacturer: BECTON, DICKINSON & CO. (BROKEN BOW)
• Manufacturer Address: 150 SOUTH 1ST AVENUE BROKEN BOW NE 68822 US 68822

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Other	2019-12-27