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

Catalog Number 337170

Device Problem Fluid/Blood Leak (1250)

Patient Problem No Patient Involvement (2645)

Event Date 09/15/2020

Event Type  malfunction  

Manufacturer Narrative

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 during use with a bd facs sample prep assistant ii leakage of sheath prior to waste tank occurred outside of instrument.The following information was provided by the initial reporter: flooding reported.Are you using this product for clinical diagnostic tests? 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? n/a.Software version? (b)(6).List of parts shipped (include foc): n/a.Rma required? n/a.Was there a fluidic leak or spill? yes.No erroneous results, no one was injured in the making of this case & there were no burning smells or odd sounds.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.Leak or drip was not under pressure.Additionally, on 2020-9-29 the bd tech provided the following additional information: sheath, to flush sample probe.Wash tower where the probe washes.Before waste tank.

Event Description

It was reported that during use with a bd facs sample prep assistant ii leakage of sheath prior to to waste tank occurred outside of instrument.The following information was provided by the initial reporter: flooding reported.Are you using this product for clinical diagnostic tests? 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? n/a software version? 9 list of parts shipped (include foc): n/a rma required? n/a was there a fluidic leak or spill? yes.No erroneous results, no one was injured in the making of this case & there were no burning smells or odd sounds.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 7.Leak or drip was not under pressure.Additionally, on 2020-9-29 the bd tech provided the following additional information: sheath, to flush sample probe.Wash tower where the probe washes.Before waste tank.

Manufacturer Narrative

H6: investigation summary customer called to report the problem.Customer declined to troubleshoot the issue in favor of onsite service.Fse removed and cleaned waste filter and reset the carousel position.Tested system.The instrument is testing without errors and has been returned to the customer for normal use.The instrument is currently operational.Fluids were contained within the system.No one was exposed to any biological hazards or bodily fluids.Review of the dhr for serial number: (b)(6) and (b)(6) was reviewed.The instrument met all the manufacturing specifications prior to release.Root cause: based on the investigation results, the root cause was a dirty filter and out of position carousel.H3 other text : see h10.

• Brand Name: BD FACS SAMPLE PREP ASSISTANT II
• Type of Device: STATION, PIPPETTING DILUTING CLINICAL
• Manufacturer (Section D): BECTON, DICKINSON AND COMPANY, BD BIOSCIENCES; 2350 qume drive; san jose CA 95131
• MDR Report Key: 10643449
• MDR Text Key: 212055114
• Report Number: 2916837-2020-00170
• 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: 02/05/2021

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: 09/15/2020
• Initial Date FDA Received: 10/07/2020
• Supplement Dates Manufacturer Received: 02/05/2021
• Supplement Dates FDA Received: 02/05/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other