MAUDE Adverse Event Report: BECTON, DICKINSON AND COMPANY, BD BIOSCIENCES BD FACS LYSEWASH ASSISTANT; STATION, PIPETTING DILUTING CLINICAL USE

Catalog Number 347190

Device Problem Fluid/Blood Leak (1250)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/25/2020

Event Type  malfunction  

Manufacturer Narrative

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 the waste line leaked outside of instrument with a bd facs¿ lysewash assistant.The following information was provided by the initial reporter: it was reported that the unit is leaking from under the cover.Customer problem: unit is leaking from under the cover.Steps taken with customer/troubleshooting: customer unable to determine where the leak is coming from.Asked customer to turn unit off and unplug from power outlet.Next steps (if necessary): dispatch.Are you using this product for clinical diagnostic test? yes.Were erroneous results reported and used to treat a patient? no.Was there any injury or potential injury? no.Resolution achieved? no.Follow up required? no.Software version? no.List of parts shipped (include foc): no.Rma required? no.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? no.What was the fluid that leaked/spilled? waste, customer used ppe in the process of cleaning leak.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.

Event Description

It was reported that the waste line leaked outside of instrument with a bd facs¿ lysewash assistant.The following information was provided by the initial reporter: it was reported that the unit is leaking from under the cover.Customer problem: unit is leaking from under the cover steps taken with customer/troubleshooting: customer unable to determine where the leak is coming from.Asked customer to turn unit off and unplug from power outlet.Next steps (if necessary): dispatch are you using this product for clinical diagnostic test? yes were erroneous results reported and used to treat a patient? no was there any injury or potential injury? no resolution achieved? no follow up required? no software version? no list of parts shipped (include foc): no rma required? no 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? no 4.What was the fluid that leaked/spilled? waste, customer used ppe in the process of cleaning leak 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.

Manufacturer Narrative

After further review mfr#(b)(4)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 LYSEWASH ASSISTANT
• Type of Device: STATION, PIPETTING DILUTING CLINICAL USE
• Manufacturer (Section D): BECTON, DICKINSON AND COMPANY, BD BIOSCIENCES; 2350 qume drive; san jose CA 95131
• MDR Report Key: 10683220
• MDR Text Key: 238137178
• Report Number: 2916837-2020-00190
• Device Sequence Number: 1
• Product Code: JQW
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• 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: 06/15/2021

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: 347190
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 09/25/2020
• Initial Date FDA Received: 10/15/2020
• Supplement Dates Manufacturer Received: 06/15/2021
• Supplement Dates FDA Received: 06/15/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other