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

Catalog Number 650685

Device Problem Fluid/Blood Leak (1250)

Patient Problem No Patient Involvement (2645)

Event Date 11/10/2020

Event Type  malfunction  

Manufacturer Narrative

Common device name: automated pipetting, dilutin and speciment processing workstations for flow cytometric analysis.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 bd facs¿ sample prep assistant biohazard fluid leaked outside of instrument.There was no impact to user or patient.The following information was provided by the initial reporter: it was reported that the instrument is leaking internally.Most likely sheath and di water.It was not under pressure.Wash station overflowed when doing rinse of the probe.Was there any spray of liquid under pressure: no.Was the waste mixed with decontaminate/bleach? no.Steps taken with customer/troubleshooting: the customer reports that the instrument is leaking internally and the washstation is overflowing.The instrument has been placed down and out of service.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? na.List of parts shipped (include foc): na.Rma required? na.Was there a fluidic leak or spill? yes.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? unknown.What is the source of leak/spill? (waste or non-waste line) unknown.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.The customer reports that the instrument is leaking internally and the washstation is overflowing.

Event Description

It was reported that while using bd facs¿ sample prep assistant biohazard fluid leaked outside of instrument.There was no impact to user or patient.The following information was provided by the initial reporter: it was reported that the instrument is leaking internally.Most likely sheath and di water.It was not under pressure.Wash station overflowed when doing rinse of the probe.Was there any spray of liquid under pressure: no.Was the waste mixed with decontaminate/bleach? no.Steps taken with customer/troubleshooting: the customer reports that the instrument is leaking internally and the washstation is overflowing.The instrument has been placed down and out of service.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? na.List of parts shipped (include foc): na.Rma required? na.Was there a fluidic leak or spill? yes.1.Was the leak/spill contained within the instrument? no.2.Was the leak/spill in a customer accessible location? yes.3.What was the fluid that leaked/spilled? unknown 4.What is the source of leak/spill? (waste or non-waste line) unknown.5.Was the customer exposed to blood or bodily fluids? no.6.Was there any physical harm to the customer as a result of the leak? no.The customer reports that the instrument is leaking internally and the washstation is overflowing.

Manufacturer Narrative

After further review mfr#2916837-2020-00295 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: 10968366
• MDR Text Key: 230533016
• Report Number: 2916837-2020-00295
• 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: 650685
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 11/10/2020
• Initial Date FDA Received: 12/08/2020
• 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