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

Catalog Number	663518
Medical Device Problem Code	Contamination (1120)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/01/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H.3.A device evaluation and/or device history review is anticipated but is not complete.Upon completion, a supplemental report will be filed.
Event or Problem Description
It was reported that carryover was observed on patient samples during use with the bd facslyric¿.The following information was provided by the initial reporter: contamination: 1.Were patient samples contaminated or was there carryover (cross-contamination/mixing) between patient samples? if no, no further questions required.Patient samples contaminated, carryover between patient samples, unknown - go to question #2.Carryover between patient samples.2.Please describe any additional details: go to patient samples checklist.Customer noticed carryover after seeing the second tube acquire.Customer stopped acquisition and contacted for service.
Additional Manufacturer Narrative
The following field has been updated with corrected information: h.6 imdrf annex g: g04034.H.6 investigation summary: based on the investigation results, the reported issue of sample carryover was confirmed.Investigation results that were performed on the indicated failure mode were the following: manufacturing, defect, service history and complaint trends were reviewed.Device history record (dhr) reviewed.The instrument met all the manufacturing specifications prior to release.A return sample was not requested for evaluation.Fse replaced a broken fitting on the waste line and this part was from trunk stock.The replacement resolved the issue.Potential cause was due to a broken fitting on the waste line of the manual tube load port.Although the instrument was used for diagnostic testing, the issue was resolved before any patient sample results were used for any diagnosis or treatment.
Event or Problem Description
It was reported that carryover was observed on patient samples during use with the bd facslyric¿.The following information was provided by the initial reporter: contamination: 1.Were patient samples contaminated or was their carryover (cross-contamination/mixing) between patient samples? if no, no further questions required.Patient samples contaminated, carryover between patient samples, unknown - go to question #2.Carryover between patient samples.2.Please describe any additional details: go to patient samples checklist.Customer noticed carryover after seeing the second tube acquire.Customer stopped acquisition and contacted for service.

• Brand Name: BD FACSLYRIC¿
• Common Device Name: FLOW CYTOMETRIC REAGENTS AND ACCESS
• 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: 23304691
• Report Number: 3027394506-2025-00044
• Device Sequence Number: 18636961
• Product Code: OYE
• UDI-Device Identifier: 00382906635181
• UDI-Public: (01)00382906635181(11)200303
• Combination Product (Y/N): N
• Initial Reporter State: CT
• Initial Reporter Country: US
• PMA/510(K) Number: K201814
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/07/2026

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: 10/01/2025
• Supplement Date Received by Manufacturer: 01/06/2026
• Initial Report FDA Received Date: 10/15/2025
• Supplement Report FDA Received Date: 01/07/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/03/2020
• 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