FACSARIA? FUSION 6B/3R/3V ACDU W/HOOD 656700G5

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 2020-03-02 for FACSARIA? FUSION 6B/3R/3V ACDU W/HOOD 656700G5 manufactured by Becton, Dickinson And Company, Bd Biosciences.

MAUDE Entry Details

• Report Number: 2916837-2020-00001
• MDR Report Key: 9774946
• Report Source: FOREIGN,OTHER,USER FACILITY
• Date Received: 2020-03-02
• Date of Report: 2020-02-13
• Date of Event: 2020-02-07
• Date Mfgr Received: 2020-02-12
• Device Manufacturer Date: 2019-03-22
• Date Added to Maude: 2020-03-02
• 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 AND COMPANY, BD BIOSCIENCES
• Manufacturer Street: 2350 QUME DRIVE
• Manufacturer City: SAN JOSE CA 95131
• Manufacturer Country: US
• Manufacturer Postal Code: 95131
• Single Use: 3
• Previous Use Code: 3
• Event Type: 3
• Type of Report: 3

Device Details

• Brand Name: FACSARIA? FUSION 6B/3R/3V ACDU W/HOOD
• Generic Name: FLOW CYTOMETER
• Product Code: OYE
• Date Received: 2020-03-02
• Catalog Number: 656700G5
• Device Availability: *
• Device Eval'ed by Mfgr: R
• Device Sequence No: 1
• Device Event Key: 0
• Manufacturer: BECTON, DICKINSON AND COMPANY, BD BIOSCIENCES
• Manufacturer Address: 2350 QUME DRIVE SAN JOSE CA 95131 US 95131

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Required No Informationntervention	2020-03-02