BD DISPOSABLE CORNWALL? SYRINGE SYSTEM 305224

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,other,user facility report with the FDA on 2020-01-28 for BD DISPOSABLE CORNWALL? SYRINGE SYSTEM 305224 manufactured by Bd Infusion Therapy Systems Inc. S.a. De C.v..

MAUDE Entry Details

• Report Number: 9610847-2020-00023
• MDR Report Key: 9638602
• Report Source: FOREIGN,OTHER,USER FACILITY
• Date Received: 2020-01-28
• Date of Report: 2020-01-21
• Date of Event: 2020-01-02
• Date Mfgr Received: 2020-01-02
• Device Manufacturer Date: 2018-02-06
• Date Added to Maude: 2020-01-28
• 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: BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V.
• Manufacturer Street: PERIFERICO LUIS DONALDO COLOSIO NO. 579
• Manufacturer City: NOGALES
• Manufacturer Country: MX
• Single Use: 3
• Previous Use Code: 3
• Event Type: 3
• Type of Report: 3

Device Details

• Brand Name: BD DISPOSABLE CORNWALL? SYRINGE SYSTEM
• Generic Name: LIQUID MEDICATION DISPENSER
• Product Code: KYX
• Date Received: 2020-01-28
• Catalog Number: 305224
• Lot Number: 8019542
• Device Availability: *
• Device Eval'ed by Mfgr: R
• Device Sequence No: 1
• Device Event Key: 0
• Manufacturer: BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V.
• Manufacturer Address: PERIFERICO LUIS DONALDO COLOSIO NO. 579 NOGALES MX

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Other	2020-01-28