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	04/03/2025
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 while using bd facslyric¿ it failed to pull away aspiration completely during sit flush causing carry over between samples.No patient injuries were reported.The following information was provided by the initial reporter: waste is not being pulled away completely.Machine failed to pull away aspiration during sit flush causing carry over between samples.
Additional Manufacturer Narrative
H.6: investigation summary: based on the investigation results, the reported contamination carry over issue was confirmed.The cause of the complaint was a clogged waste line.The customer attempted to resolve the issue on their own by replacing the sample line, but this did not resolve the issue.A field service engineer (fse) was sent onsite for a field service visit, and they were able to confirm that there was a clog in the sit flush drain line.The fse then cleared the debris with warm bleached water and several sit flushes.Finally, the fse completed pqc and abort count checks and confirmed that the instrument was performing to bd specifications.There was no impact to customer or patient safety due to this event.A return sample was not requested for evaluation as the root cause of the issue was identified without requiring a sample analysis.4 complaints regarding similar issues regarding clogged tubing and resulting carryover were identified within 12 months of this event.Device history record (dhr) review was not required as the root cause was identified in the field.
Event or Problem Description
It was reported that while using bd facslyric¿ it failed to pull away aspiration completely during sit flush causing carry over between samples.No patient injuries were reported.The following information was provided by the initial reporter: waste is not being pulled away completely machine failed to pull away aspiration during sit flush causing carry over between samples.

• 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: 21892324
• Report Number: 3027394506-2025-00019
• Device Sequence Number: 15478236
• Product Code: OYE
• UDI-Device Identifier: 00382906635181
• UDI-Public: (01)00382906635181(11)220907
• Combination Product (Y/N): N
• Initial Reporter State: TN
• 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: Other,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/23/2025

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: 04/03/2025
• Supplement Date Received by Manufacturer: 07/23/2025
• Initial Report FDA Received Date: 04/23/2025
• Supplement Report FDA Received Date: 07/28/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/07/2022
• 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