MAUDE Adverse Event Report: BECTON DICKINSON AND COMPANY BD BIOSCIENCES BD FACSCANTO¿ II SYSTEM W/FLUIDICS CART; COUNTER, DIFFERENTIAL CELL

Catalog Number	338962
Medical Device Problem Code	Improper or Incorrect Procedure or Method (2017)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/02/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
D.4.Medical device expiration date: na.H.3.A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.
Event or Problem Description
It was reported that during use with bd facscanto¿ ii system w/fluidics cart error message for waste was received and bypassed.There was no report of any patient or user impact.The following information was provided by the initial reporter: the customer reported that waste is showing as full even though it is empty 1.Are you running patient samples for diagnostic test? (if yes or unknown, go to question #2.If no, no further questions required.): yes.2.Was there an error message? (if yes, go to question #3.If no, no further questions required.): yes.3.Did the customer bypass the error message? (if yes, go to question #4.If no, no further questions required.): yes.
Additional Manufacturer Narrative
The following fields have been updated with corrected information: g.1 - reporting office contact - (b)(4).G.1 - manufacturing site contact - (b)(4).G.1 - reporting office- becton dickinson and company bd biosciences.H6.Investigation summary: based on the investigation results, the reported issue of the waste showing as full even though it was empty was not confirmed.Investigation results that were performed on the indicated failure mode were the following: review of the complaint trend, defect trend, device history record review, and risk analysis.The cause of the waste tank error reported in the complaint was not identified because the customer did not respond back to the fse.Subsequent visits by the field service engineer resulted in successful preventive maintenance and the instrument is running as expected.Complaints received for this device and reported condition will continue to be tracked and trended.Information will be captured on trend reports and monitored.Our business team regularly reviews the collected data for identification of emerging trends.
Event or Problem Description
It was reported that during use with bd facscanto¿ ii system w/fluidics cart error message for waste was received and bypassed.There was no report of any patient or user impact.The following information was provided by the initial reporter: the customer reported that waste is showing as full even though it is empty 1.Are you running patient samples for diagnostic test? (if yes or unknown, go to question #2.If no, no further questions required.): yes.2.Was there an error message? (if yes, go to question #3.If no, no further questions required.): yes.3.Did the customer bypass the error message? (if yes, go to question #4.If no, no further questions required.): yes.

• Brand Name: BD FACSCANTO¿ II SYSTEM W/FLUIDICS CART
• Common Device Name: COUNTER, DIFFERENTIAL CELL
• Manufacturer (Section D): BECTON DICKINSON AND COMPANY BD BIOSCIENCES; 2350 qume drive; san jose CA 95131
• Manufacturer (Section G): BECTON, DICKINSON AND COMPANY, BD BIOSCIENCES; 2350 qume drive; san jose CA 95131
• Manufacturer Contact: fahmy razak - mdr ; 2350 qume drive; san jose, CA 95131 ; 4089542435
• MDR Report Key: 17971962
• Report Number: 2916837-2023-00202
• Device Sequence Number: 7119771
• Product Code: OYE
• UDI-Device Identifier: 00382903389629
• UDI-Public: (01)00382903389629
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K141468
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/11/2024

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 Catalogue Number: 338962
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/02/2023
• Supplement Date Received by Manufacturer: 07/11/2024
• Initial Report FDA Received Date: 10/20/2023
• Supplement Report FDA Received Date: 07/11/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/22/2012
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown