MAUDE Adverse Event Report: BECTON, DICKINSON AND COMPANY, BD BIOSCIENCES BD FACSLYRIC¿; FLOW CYTOMETRIC REAGENTS AND ACCESSORIES

Catalog Number	662875
Medical Device Problem Code	Contamination (1120)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/04/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
E.1- initial reporter e-mail: (b)(6).E.2- initial reporter addr 1: (b)(6).G.1- pma / 510(k)#: k170974; k201814.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 usage of bd facslyric¿ carryover between patient samples was observed.The following information was provided by the initial reporter: it was reported by the customer that there was carry over.
Additional Manufacturer Narrative
H.6.Investigation summary: based on the investigation results, the cause of the complaint was confirmed to be due to dirty sit flush tubing.The customer had reported that the instrument was exhibiting carryover between samples, and a field service engineer (fse) was sent onsite to investigate the issue.The fse confirmed the issue and proceeded to clean the sit flush tubing, reseat the pinch valve, and changed the assay sit flushes from 1 to 3.The instrument was then functioning as expected and was returned to the customer.There was no impact to patient diagnosis or treatment.A return sample was not requested for evaluation as the root cause of the issue was identified without requiring a sample analysis.
Event or Problem Description
It was reported that during usage of bd facslyric¿ carryover between patient samples was observed.The following information was provided by the initial reporter: it was reported by the customer that there was carry over.

• Brand Name: BD FACSLYRIC¿
• Common Device Name: FLOW CYTOMETRIC REAGENTS AND ACCESSORIES
• 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: 23089541
• Report Number: 3027394506-2025-00040
• Device Sequence Number: 10516951
• Product Code: OYE
• UDI-Device Identifier: 00382906628756
• UDI-Public: (01)00382906628756(11)200727
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• PMA/510(K) Number: BK230835
• 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): 10/31/2025

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: 662875
• 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: 09/04/2025
• Supplement Date Received by Manufacturer: 10/31/2025
• Initial Report FDA Received Date: 09/18/2025
• Supplement Report FDA Received Date: 11/04/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/27/2020
• 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