MAUDE Adverse Event Report: BECTON, DICKINSON AND COMPANY, BD BIOSCIENCES BD FACSCANTO¿ II FLOW CYTOMETER; COUNTER, DIFFERENTIAL CELL

Catalog Number	338960
Medical Device Problem Code	Unintended Electrical Shock (4018)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/03/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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 while using bd facscanto¿ ii flow cytometer the customer got electrical shock.No injury or treatment was reported.The following information was provided by the initial reporter: electrical shock from top of carrousel.No injury to patient.Instrument shut off and isolated.
Event or Problem Description
It was reported that while using bd facscanto¿ ii flow cytometer the customer got electrical shock.No injury or treatment was reported.The following information was provided by the initial reporter: electrical shock from top of carrousel.No injury to patient.Instrument shut off and isolated.
Additional Manufacturer Narrative
H.6 investigation summary: based on the investigation results, the reported issue of electrical shock from top of carousel was confirmed.Investigation results that were performed on the indicated failure mode were the following: complaint history review, service history review, risk review.The potential cause was not determined; however, the field service engineer inspected the power cord connection and grounding of the overall cytometer and found no damage.The fse also cleaned and reinstalled the main loader cable connector and tested the instrument confirming everything passed was working within specification.The customer noted there were no burns or injury as a result of the issue.

• Brand Name: BD FACSCANTO¿ II FLOW CYTOMETER
• 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: 20201704
• Report Number: 2916837-2024-00046
• Device Sequence Number: 7546397
• Product Code: GKZ
• UDI-Device Identifier: 00382903389605
• UDI-Public: (01)00382903389605(11)120322
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K062087
• 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): 05/13/2025

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: 338960
• 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: 09/03/2024
• Supplement Date Received by Manufacturer: 05/13/2025
• Initial Report FDA Received Date: 09/12/2024
• Supplement Report FDA Received Date: 05/13/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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