YUEH CENTESIS DISPOSABLE CATHETER NEEDLE N/A DTVN-5.0-19-7.0-YUEH

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,user f report with the FDA on 2019-08-07 for YUEH CENTESIS DISPOSABLE CATHETER NEEDLE N/A DTVN-5.0-19-7.0-YUEH manufactured by Cook Inc.

MAUDE Entry Details

• Report Number: 1820334-2019-01947
• MDR Report Key: 8869241
• Report Source: COMPANY REPRESENTATIVE,USER F
• Date Received: 2019-08-07
• Date of Report: 2019-08-07
• Date of Event: 2019-08-05
• Date Mfgr Received: 2019-08-05
• Device Manufacturer Date: 2019-06-13
• Date Added to Maude: 2019-08-07
• 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
• Health Professional: 3
• Initial Report to FDA: 3
• Report to FDA: 3
• Event Location: 3
• Manufacturer Contact: MR. LARRY POOL
• Manufacturer Street: 750 DANIELS WAY
• Manufacturer City: BLOOMINGTON IN 47404
• Manufacturer Country: US
• Manufacturer Postal: 47404
• Manufacturer Phone: 8123392235
• Manufacturer G1: COOK INC
• Manufacturer Street: 750 DANIELS WAY
• Manufacturer City: BLOOMINGTON IN 47404
• Manufacturer Country: US
• Manufacturer Postal Code: 47404
• Single Use: 3
• Previous Use Code: 3
• Event Type: 3
• Type of Report: 3

Device Details

• Brand Name: YUEH CENTESIS DISPOSABLE CATHETER NEEDLE
• Generic Name: GCB NEEDLE, CATHETER
• Product Code: GCB
• Date Received: 2019-08-07
• Model Number: N/A
• Catalog Number: DTVN-5.0-19-7.0-YUEH
• Lot Number: 9810600
• Operator: HEALTH PROFESSIONAL
• Device Availability: Y
• Device Eval'ed by Mfgr: R
• Device Sequence No: 1
• Device Event Key: 0
• Manufacturer: COOK INC
• Manufacturer Address: 750 DANIELS WAY BLOOMINGTON IN 47404 US 47404

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Life Threatening; 2. Required No Informationntervention	2019-08-07