MAUDE Adverse Event Report: BECTON, DICKINSON AND COMPANY, BD BIOSCIENCES FACSARIA FLOW CYTOMETER

Catalog Number 334079

Device Problem Fluid/Blood Leak (1250)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 11/11/2020

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 that while using facsaria¿ flow cytometer sheath under pressure sprayed outside of instrument into the users face, but not in eyes.User rinsed face and eyes with water.There was no patient impact.The following information was provided by the initial reporter: leakage from the sheath filter, sprayed and put on the customer's face.Was the leak fluid or air? fluid.Was the leak contained within the instrument? no.Was there spray of fluid under pressure? yes.Was the customer/bd personnel physically in contact with the fluid? yes.Which part of the body was in contact to the fluid? user's face.What personal protective equipment (ppe) was being worn? no face shield and goggles.Was there any impact to patient samples due to leak? no.Was customer harmed/injured? no, flow liquid sprayed on the user's face, but not in the user's eyes.Immediately the user washed her face and eyes with running water.What is the current medical status? none.

Manufacturer Narrative

After further review mfr# 2916837-2020-00280 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.

Event Description

It was reported that while using facsaria¿ flow cytometer sheath under pressure sprayed outside of instrument into the users face, but not in eyes.User rinsed face and eyes with water.There was no patient impact.The following information was provided by the initial reporter: leakage from the sheath filter, sprayed and put on the customer's face 1.Was the leak fluid or air? fluid 2.Was the leak contained within the instrument? no 3.Was there spray of fluid under pressure? yes 7.Was the customer/bd personnel physically in contact with the fluid? yes 8.Which part of the body was in contact to the fluid? user's face.9.What personal protective equipment (ppe) was being worn? no face shield and goggles 10.Was there any impact to patient samples due to leak? no 11.Was customer harmed/injured? no, flow liquid sprayed on the user's face, but not in the user's eyes.Immediately the user washed her face and eyes with running water.12.What is the current medical status? none.

• Brand Name: FACSARIA FLOW CYTOMETER
• Type of Device: NA
• Manufacturer (Section D): BECTON, DICKINSON AND COMPANY, BD BIOSCIENCES; 2350 qume drive; san jose CA 95131
• MDR Report Key: 10928529
• MDR Text Key: 234326017
• Report Number: 2916837-2020-00280
• 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: foreign,other,user facility
• Type of Report: Initial,Followup
• Report Date: 06/25/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/01/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 334079
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 06/25/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1