MAUDE Adverse Event Report: BECTON, DICKINSON AND COMPANY, BD BIOSCIENCES BD FACSYMPHONY; DIFFERENTIAL CELL COUNTER

Catalog Number 660964

Device Problem Fluid/Blood Leak (1250)

Patient Problem No Patient Involvement (2645)

Event Date 11/16/2020

Event Type  malfunction  

Manufacturer Narrative

A device evaluation and/or device history review is anticipated, but is not complete.Upon completion, a supplemental report will be filed.(b)(4).

Event Description

It was reported that bd facsymphony¿ leaked.The following information was provided by the initial reporter: "issue 1: slow flow rate made the hydrophobic filter get wet (2067804) issue 2: dcm pump does not pull fluid off the sip (2071713) material no: 660964 serial #: (b)(4).It was reported that there is a slow flow rate made the hydrophobic filter got wet.Also, the dcm pump does not pull fluid off the sip."was there a fluidic leak or spill? yes.Was there spray of fluid under pressure? no.Was the leak/spill contained within the instrument? no.Was the leak/spill in a customer accessible location? yes.What was the fluid that leaked/spilled? sheath.What is the source of leak/spill? (waste or non-waste line) waste line.Was the customer exposed to blood or bodily fluids? no.Was there any physical harm to the customer as a result of the leak no.¿.

Manufacturer Narrative

After further review mfr# 2916837-2020-00301 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 bd facsymphony¿ leaked.The following information was provided by the initial reporter: "issue 1: slow flow rate made the hydrophobic filter get wet (2067804) issue 2: dcm pump does not pull fluid off the sip (b)(6).Material no: 660964 serial no: (b)(6).It was reported that there is a slow flow rate made the hydrophobic filter got wet.Also, the dcm pump does not pull fluid off the sip."was there a fluidic leak or spill? yes.1.Was there spray of fluid under pressure? no.2.Was the leak/spill contained within the instrument? no.3.Was the leak/spill in a customer accessible location? yes.4.What was the fluid that leaked/spilled? sheath.5.What is the source of leak/spill? (waste or non-waste line) waste line.6.Was the customer exposed to blood or bodily fluids? no.7.Was there any physical harm to the customer as a result of the leak no".

• Brand Name: BD FACSYMPHONY
• Type of Device: DIFFERENTIAL CELL COUNTER
• Manufacturer (Section D): BECTON, DICKINSON AND COMPANY, BD BIOSCIENCES; 2350 qume drive; san jose CA 95131
• MDR Report Key: 10994441
• MDR Text Key: 247274677
• Report Number: 2916837-2020-00301
• 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: other,user facility
• Type of Report: Initial,Followup
• Report Date: 06/08/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 660964
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 11/16/2020
• Initial Date FDA Received: 12/12/2020
• Supplement Dates Manufacturer Received: 06/08/2021
• Supplement Dates FDA Received: 06/09/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1