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

Catalog Number 337170

Device Problem Fluid/Blood Leak (1250)

Patient Problem No Patient Involvement (2645)

Event Date 10/01/2020

Event Type  malfunction  

Manufacturer Narrative

Date of event: unknown.The date received by manufacturer has been used for this field.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 sheath under pressure spayed outside of instrument with a bd facs sample prep assistant ii.The following information was provided by the initial reporter: it was reported that the wash station is overflowing.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? yes.Was the leak/spill contained within the instrument? yes.Was the leak/spill in a customer accessible location? yes.What was the fluid that leaked/spilled? customer states sheath.What is the source of leak/spill? (waste or non-waste line) waste and non- waste.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

Investigation summary : review of the dhr for serial number: (b)(6) was reviewed.The instrument met all the manufacturing specifications prior to release.Per fse report: wash station was not overflowing.The problem was that a clogged probe caused the fluid line tubing to come off it.Removed the clog from the probe tip and thoroughly flushed the probe.Reattached the tubing to the top of the probe.Aligned the probe to the reference point.Fluids were contained within the system.No one was exposed to any biological hazards or bodily fluids.The instrument is operating as intended and testing without errors.I have returned it to the lab for normal use.

Event Description

It was reported that sheath under pressure spayed outside of instrument with a bd facs sample prep assistant ii.The following information was provided by the initial reporter: it was reported that the wash station is overflowing.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? yes.2.Was the leak/spill contained within the instrument? yes.3.Was the leak/spill in a customer accessible location? yes.4.What was the fluid that leaked/spilled? customer states sheath.5.What is the source of leak/spill? (waste or non-waste line) waste and non- waste.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 FACS SAMPLE PREP ASSISTANT II
• 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: 10711891
• MDR Text Key: 244131119
• Report Number: 2916837-2020-00204
• 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: 02/09/2021

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: 337170
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 10/01/2020
• Initial Date FDA Received: 10/21/2020
• Supplement Dates Manufacturer Received: 02/09/2021
• Supplement Dates FDA Received: 02/09/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1