MAUDE Adverse Event Report: BECTON, DICKINSON AND COMPANY, BD BIOSCIENCES BD FACSCANTO; SEE H.10

Model Number	339473
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	05/27/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Common device name: flow cytometric reagents and accessories.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 or Problem Description
It was reported that leakage of waste occurred outside of instrument with a bd facscanto¿ ii cytometer ivd 5/3 system.The following information was provided by the initial reporter: user reported fluid leakage from the cytometer.Additionally, on 2020-05-29 the bd sales consultant provided the following additional information: was the leak contained within the instrument? yes.Was the leak in a customer accessible location? yes.What was the fluid that leaked? unknown what is the source of leak a waste line or non-waste line? unknown.Was the customer exposed to blood or bodily fluids? yes.Was there any physical harm to the customer as a result of the leak? no.Was the customer exposed to blood or bodily fluids? yes.Was there any physical harm to the customer as a result of the leak? no.Additionally, on 2020-06-09 the fse provided the following additional information: it was leakage from instrument.We do not know what it was, facsclean or from waste line.The customer did not have any physical contact (like clothing, skin etc.).Customer used medical gloves to clean the puddle.There was not any impact to patient samples due to leak.
Additional Manufacturer Narrative
After further evaluation of the complaint, it has been determined that the previously submitted mfr report # 2916837-2020-00025 was sent in error.There was no skin or mucous membrane exposure and the leak was contained within the instrument, therefore, is not considered to be a reportable malfunction.
Event or Problem Description
It was reported that leakage of waste occurred outside of instrument with a bd facscanto¿ ii cytometer ivd 5/3 system.The following information was provided by the initial reporter: user reported fluid leakage from the cytometer.Additionally, on 2020-05-29 the bd sales consultant provided the following additional information: was the leak contained within the instrument? yes.Was the leak in a customer accessible location? yes.What was the fluid that leaked? unknown.What is the source of leak -- a waste line or non-waste line? unknown.Was the customer exposed to blood or bodily fluids? yes.Was there any physical harm to the customer as a result of the leak? no.Was the customer exposed to blood or bodily fluids? yes.Was there any physical harm to the customer as a result of the leak? no.Additionally, on 2020-06-09 the fse provided the following additional information: it was leakage from instrument.We do not know what it was, facsclean or from waste line.The customer did not have any physical contact (like clothing, skin etc.).Customer used medical gloves to clean the puddle.There was not any impact to patient samples due to leak.

• Brand Name: BD FACSCANTO
• Common Device Name: SEE H.10
• Manufacturer (Section D): BECTON, DICKINSON AND COMPANY, BD BIOSCIENCES; 2350 qume drive; san jose CA 95131
• MDR Report Key: 10158622
• Report Number: 2916837-2020-00025
• Device Sequence Number: 3600048
• Product Code: OYE
• UDI-Device Identifier: 00382903394739
• UDI-Public: 00382903394739
• Combination Product (Y/N): N
• Initial Reporter Country: PL
• PMA/510(K) Number: K141468
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,other,user facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/13/2020

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
• Operator of Device: Other
• Device Model Number: 339473
• Device Catalogue Number: 339473
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 05/27/2020
• Supplement Date Received by Manufacturer: 05/27/2020
• Initial Report FDA Received Date: 06/16/2020
• Supplement Report FDA Received Date: 07/13/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other