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 09/09/2020

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: wash station suction blocked.Additionally, the work order provided the following additional information: waste line traced from the washing station to the waste - the connector in front of the waste container is no longer continuous.

Manufacturer Narrative

H6: investigation summary: the connector in front of the waste container is no longer continuous.The connector pn: 333089 was replaced.System passed functional check.Primed performed several times.System is ok and can be used again.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.Review of the dhr for serial number: x0112 and pn647205 was reviewed.The instrument met all the manufacturing specifications prior to release.Based on the investigation result, and the fse¿s report the root cause was clogged connector.H3 other text : see h.10.

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: wash station suction blocked.Additionally, the work order provided the following additional information: waste line traced from the washing station to the waste - the connector in front of the waste container is no longer continuous.

• 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: 10599629
• MDR Text Key: 238137011
• Report Number: 2916837-2020-00146
• 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: 01/19/2021

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
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 09/09/2020
• Initial Date FDA Received: 09/29/2020
• Supplement Dates Manufacturer Received: 01/19/2021
• Supplement Dates FDA Received: 01/21/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other