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

Model Number	338960
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/07/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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 the bd facscanto¿ ii flow cytometer that there was a broken fluidics cart.The following information was provided by the initial reporter: coupling broken fluidicscart left side sheath tubing.
Additional Manufacturer Narrative
After further evaluation of the complaint, it has been determined that the previously submitted report 2916837-2022-00347 was sent in error.There was no report of serious injury, medical intervention, or reportable device malfunction.Therefore this is not considered to be a reportable malfunction.
Event or Problem Description
It was reported that while using the bd facscanto¿ ii flow cytometer that there was a broken fluidics cart.The following information was provided by the initial reporter: coupling broken fluidicscart left side sheath tubing.

• 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: phillip emmert ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 15801185
• Report Number: 2916837-2022-00347
• Device Sequence Number: 17903364
• Product Code: GKZ
• UDI-Device Identifier: 00382903389605
• UDI-Public: 00382903389605
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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: Foreign,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/13/2023

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: 338960
• 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: 11/07/2022
• Supplement Date Received by Manufacturer: 11/07/2022
• Initial Report FDA Received Date: 11/15/2022
• Supplement Report FDA Received Date: 02/15/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/22/2013
• 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