MAUDE Adverse Event Report: BECTON, DICKINSON AND COMPANY, BD BIOSCIENCES BD FACS ARIA

Catalog Number 335221

Device Problem Fluid/Blood Leak (1250)

Patient Problem No Patient Involvement (2645)

Event Date 12/08/2020

Event Type  malfunction  

Manufacturer Narrative

Medical device expiration date: na.A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.(b)(4).

Event Description

It was reported while using bd facs aria¿ waste leakage occurred outside of instrument.User impact was not reported.The following information was provided by the initial reporter: it was reported that the closed loop nozzle becomes wet when instrument stream is running.Was the fluid contained within the instrument? no.Was the leak in a customer accessible location? yes.What was the fluid that leaked? waste.What is the source of leak -- waste line or non-waste line? waste.If waste line, whether it is mixed with bleach or decontaminate? no.

Event Description

It was reported while using bd facs aria¿ waste leakage occurred outside of instrument.User impact was not reported.The following information was provided by the initial reporter: it was reported that the closed loop nozzle becomes wet when instrument stream is running.Was the fluid contained within the instrument? no.2.Was the leak in a customer accessible location? yes.3.What was the fluid that leaked? waste.4.What is the source of leak -- waste line or non-waste line? waste.5.If waste line, whether it is mixed with bleach or decontaminate? no.

Manufacturer Narrative

After further review mfr#: 2916837-2020-00330 is no longer reportable.This device is for research use only and is not being used for diagnostic testing or patient treatment and is therefore not subject to mdr reporting.

• Brand Name: BD FACS ARIA
• Type of Device: NA
• Manufacturer (Section D): BECTON, DICKINSON AND COMPANY, BD BIOSCIENCES; 2350 qume drive; san jose CA 95131
• MDR Report Key: 11088802
• MDR Text Key: 246319977
• Report Number: 2916837-2020-00330
• Device Sequence Number: 1
• Product Code: GKZ
• Combination Product (y/n): N
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 07/30/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/29/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 335221
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/30/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1