MAUDE Adverse Event Report: BECTON, DICKINSON AND COMPANY, BD BIOSCIENCES BD FACS SAMPLE PREP ASSISTANT; SEE H.10

Catalog Number 650686

Device Problem Fluid/Blood Leak (1250)

Patient Problem No Patient Involvement (2645)

Event Date 01/29/2021

Event Type  malfunction  

Manufacturer Narrative

Common device name: automated pipetting, diluting and specimen processing workstations for flow cytometric analysis.Medical device expiration date: unknown.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 bd facs¿ sample prep assistant waste leaked outside of instrument.There was no user impact.The following information was provided by the initial reporter: it was reported that the wash tower is flowing.Are you using this product for clinical diagnostic test? no.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? yes, customer donned the required ppe while cleaning up the spill.What was the fluid that leaked/spilled? waste and sheath fluid.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 while using bd facs¿ sample prep assistant waste leaked outside of instrument.There was no user impact.The following information was provided by the initial reporter: it was reported that the wash tower is flowing.Are you using this product for clinical diagnostic test? no 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? yes, customer donned the required ppe while cleaning up the spill 4.What was the fluid that leaked/spilled? waste and sheath fluid 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#2916837-2021-00059 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 SAMPLE PREP ASSISTANT
• Type of Device: SEE H.10
• Manufacturer (Section D): BECTON, DICKINSON AND COMPANY, BD BIOSCIENCES; 2350 qume drive; san jose CA 95131
• MDR Report Key: 11375329
• MDR Text Key: 252948592
• Report Number: 2916837-2021-00059
• Device Sequence Number: 1
• Product Code: PER
• 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: 06/17/2021

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: 650686
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 01/29/2021
• Initial Date FDA Received: 02/24/2021
• Supplement Dates Manufacturer Received: 06/17/2021
• Supplement Dates FDA Received: 06/18/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1