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

Catalog Number	663518
Medical Device Problem Code	Contamination (1120)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/17/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
E.1.Initial reporter phone #: (b)(6).E.1.Initial reporter facility name: (b)(6).G.5.Pma / 510(k) additional #170974; 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 use with bd facslyric¿ flow cytometer carryover involving patient samples occurred.There was no report of patient impact.The following information was provided by the initial reporter, translated from chinese to english: large sample residue.
Additional Manufacturer Narrative
H.6: investigation summary: based on the investigation results, the reported issue for the large sample residue was confirmed.Investigation results that were performed on the indicated failure mode were the following: device history review (dhr), complaint history review, and service history review.The potential cause for the large sample residue was faulty pump and degasser.The field service representative (fsr) replaced the faulty parts.After the replacement, the instrument was tested and was confirmed to be performing according to specifications.
Event or Problem Description
It was reported that during use with bd facslyric¿ flow cytometer carryover involving patient samples occurred.There was no report of patient impact.The following information was provided by the initial reporter, translated from chinese to english: large sample residue.

• Brand Name: BD FACSLYRIC¿ FLOW CYTOMETER
• 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: 22399344
• Report Number: 3027394506-2025-00031
• Device Sequence Number: 4901856
• Product Code: OYE
• UDI-Device Identifier: 00382906635181
• UDI-Public: (01)00382906635181(11)230419
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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,Foreign,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/08/2025

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: 663518
• 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: 06/17/2025
• Supplement Date Received by Manufacturer: 09/08/2025
• Initial Report FDA Received Date: 07/03/2025
• Supplement Report FDA Received Date: 09/09/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/19/2023
• 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