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	Contamination of Device Ingredient or Reagent (2901)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/10/2025
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 during use with bd facscanto¿ ii system w/fluidics cart bleach mixed with patient samples which impacted patient results.There was no impact to patient.The following information was provided by the initial reporter: it was reported by the customer that bleach is getting in to samples.
Event or Problem Description
It was reported that during use with bd facscanto¿ ii system w/fluidics cart bleach mixed with patient samples which impacted patient results.There was no impact to patient.The following information was provided by the initial reporter: it was reported by the customer that bleach is getting into samples.
Additional Manufacturer Narrative
H.3.Based on the investigation results, the reported issue of unexpected results was not confirmed.The potential cause could not be determined.The fse investigated the issue, but could not reproduce the error or confirm any bleach carryover issue.The instrument was returned to operational status.This issue did not impact patient diagnosis or treatment and no user or patient was harmed or injured.The complaint sample was not requested to be returned because the replaced part is not returnable and was discarded.Review of the device history record (dhr) confirmed that the instrument met all the manufacturing specifications prior to release.

• Brand Name: BD FACSCANTO¿ II SYSTEM W/FLUIDICS CART
• Common Device Name: COUNTER, DIFFERENTIAL CELL
• Manufacturer (Section D): BECTON, DICKINSON AND COMPANY, BD BIOSCIENCES; 155 north mccarthy boulevard; milpitas CA 95035
• Manufacturer (Section G): BECTON, DICKINSON AND COMPANY, BD BIOSCIENCES; 155 north mccarthy boulevard; milpitas CA 95035
• Manufacturer Contact: fahmy razak - mdr ; 155 north mccarthy boulevard; milpitas, CA 95035 ; 8772328995
• MDR Report Key: 21333368
• Report Number: 3027394506-2025-00001
• Device Sequence Number: 7865841
• Product Code: OYE
• UDI-Device Identifier: 00382903389629
• UDI-Public: (01)00382903389629(11)120330
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• 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,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/14/2025

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: 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: 01/13/2025
• Supplement Date Received by Manufacturer: 03/14/2025
• Initial Report FDA Received Date: 02/07/2025
• Supplement Report FDA Received Date: 03/14/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/30/2012
• 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