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

Catalog Number	663518
Medical Device Problem Code	Incorrect, Inadequate or Imprecise Result or Readings (1535)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/05/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that carryover was observed in patient samples during use with the bd facslyric¿.The following information was provided by the initial reporter: were patient samples contaminated or was there carryover (cross-contamination/mixing) between patient samples? carryover between patient samples.Please describe any additional details: go to patient samples checklist.Spoke with customer and she told me they are having issues with carryover between samples when using the manual mode.That is why they placed call.System will not be used until serviced.System is having carryover issues.
Additional Manufacturer Narrative
D4: unique identification number: (b)(4).H3.Investigation summary: based on the investigation results, the reported issue regarding carryover was confirmed.Investigation results that were performed on the indicated failure mode were the following: the potential cause for the carryover was partially clogged sample line and poor sit flush aspiration.The customer reported an issue regarding their system having carryover issues.They noted that the carryover only happens when running manually with tubes.The field service representative (fsr) performed a service visit.They replaced the sample line and flushed out the valve v8 pinch valve tubing using bleach solution.They performed a series of calibration and alignment to verify functionality.After the works performed, the instrument was tested and was confirmed to be functioning as expected.Complaints received for this device and reported condition will continue to be tracked and trended.Information will be captured on trend reports and monitored.Our business team regularly reviews the collected data for identification of emerging trends.
Additional Manufacturer Narrative
D.4.Medical device expiration date: na.E.1.: (b)(6).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 in patient samples during use with the bd facslyric¿.The following information was provided by the initial reporter: were patient samples contaminated or was their carryover (cross-contamination/mixing) between patient samples? carryover between patient samples please describe any additional details: go to patient samples checklist spoke with customer and she told me they are having issues with carryover between samples when using the manual mode.That is why they placed call.System will not be used until serviced.System is having carryover issues.

• Brand Name: BD FACSLYRIC¿
• Common Device Name: FLOW CYTOMETRIC REAGENTS AND ACCESS
• Manufacturer (Section D): BECTON, DICKINSON AND COMPANY, BD BIOSCIENCES; 2350 qume drive; san jose CA 95131
• Manufacturer (Section G): BECTON, DICKINSON AND COMPANY, BD BIOSCIENCES; 2350 qume drive; san jose CA 95131
• Manufacturer Contact: fahmy razak - mdr ; 2350 qume drive; san jose, CA 95131 ; 4089542435
• MDR Report Key: 19537791
• Report Number: 2916837-2024-00036
• Device Sequence Number: 8338078
• Product Code: OYE
• UDI-Device Identifier: 00382906635181
• UDI-Public: (01)00382906635181(11)221104(21)Z663518000280
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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): 08/20/2024

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: 06/05/2024
• Supplement Date Received by Manufacturer: 08/20/2024
• Initial Report FDA Received Date: 06/14/2024
• Supplement Report FDA Received Date: 08/22/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/04/2022
• 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