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

Catalog Number	662878
Medical Device Problem Code	Contamination (1120)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/08/2025
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: it was reported by the customer that instrument has high carryover.Contamination checklist: 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.Instrument has high carryover.
Additional Manufacturer Narrative
The following field was updated with corrected information: h.6 imdrf annex g: g07003.H.6 investigation summary: based on the investigation results, the reported issue was not confirmed.Investigation results that were performed on the indicated failure mode were the following: the potential cause and/or resolution could not be determined due to the customer stating they have a gap in their contract on this instrument and do not want the work done at this time.The service team attempted to contact the customer several times and there was no response.Although the instrument is used for diagnostic testing, no impact to customer and patient health or safety was reported.
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: it was reported by the customer that instrument has high carryover.Contamination checklist: 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.Instrument has high carryover.

• 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: 22915362
• Report Number: 3027394506-2025-00038
• Device Sequence Number: 9055412
• Product Code: OYE
• UDI-Device Identifier: 00382906628787
• UDI-Public: (01)00382906628787(11)190523
• Combination Product (Y/N): N
• Initial Reporter State: OH
• 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): 01/09/2026

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: 662878
• 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: 08/08/2025
• Supplement Date Received by Manufacturer: 12/19/2025
• Initial Report FDA Received Date: 08/28/2025
• Supplement Report FDA Received Date: 01/12/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/23/2019
• 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