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

Model Number 647205

Device Problem Fluid/Blood Leak (1250)

Patient Problem No Patient Involvement (2645)

Event Date 09/10/2020

Event Type  malfunction  

Manufacturer Narrative

Common device name: automated pipetting, diluting and specimen 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 during use with a bd facs¿ sample prep assistant iii the waste line was leaking outside of instrument.The following information was provided by the initial reporter: it was reported that the system is not draining and is back flowing onto bench top.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.

Event Description

It was reported that during use with a bd facs¿ sample prep assistant iii the waste line was leaking outside of instrument.The following information was provided by the initial reporter: it was reported that the system is not draining and is back flowing onto bench top.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.

Manufacturer Narrative

Investigation summary : customer left a voice message describing the problem.Caller was trying to resolve the issue.Bd did not dispatch at this time.Caller left another voice message that the problem has been resolved by cleaning out the filter.The source of the leak was the blocked filter before the waste tank.Filter was cleaned out and the system is working with no issues.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) was reviewed.The instrument met all the manufacturing specifications prior to release.Based on the investigation results, the root cause cannot be determined.

• Brand Name: BD FACS SAMPLE PREP ASSISTANT III
• 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: 10606081
• MDR Text Key: 231800605
• Report Number: 2916837-2020-00150
• Device Sequence Number: 1
• Product Code: PER
• UDI-Device Identifier: 00382906472052
• UDI-Public: 00382906472052
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,other,user facility
• Type of Report: Initial,Followup
• Report Date: 02/10/2021

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 Model Number: 647205
• Device Catalogue Number: 647205
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 09/10/2020
• Initial Date FDA Received: 09/30/2020
• Supplement Dates Manufacturer Received: 02/10/2021
• Supplement Dates FDA Received: 02/10/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other