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

Catalog Number	662878
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	07/16/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
D.4.Medical device expiration date: na 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 between patient samples was observed during use with the bd facslyric¿.The following information was provided by the initial reporter: 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 -got to question #2: -carryover between patient samples carry over issue.
Additional Manufacturer Narrative
The following fields have been updated with corrected information.H.6 imdrf annex: b21.H.6 imdrf annex: c21.H.6 imdrf annex: d16.
Event or Problem Description
It was reported that carryover between patient samples was observed during use with the bd facslyric¿.The following information was provided by the initial reporter: 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 -got to question #2: carryover between patient samples carry over issue.
Event or Problem Description
It was reported that carryover between patient samples was observed during use with the bd facslyric¿.The following information was provided by the initial reporter: contamination checklist: 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 got to question #2: carryover between patient samples.Carry over issue.
Additional Manufacturer Narrative
H6 investigation summary: based on the investigation results, the reported issue for the carryover was not confirmed.Investigation results that were performed on the indicated failure mode were the following: the potential cause for the carryover could not be determined.The customer reported a complaint regarding carryover.They reported that the populations were moving intermittently.The issue could not be reproduced.The service team guided the customer to troubleshoot.The customer cleaned the instrument and purged the filter.They ran cleaning detergent for 5 minutes.They ran water after running beads and found no residuals.They verified the vacuum and waste pump circuit.After the cleaning, the instrument was tested and was confirmed to be performing according to specifications.

• 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: 19975495
• Report Number: 2916837-2024-00044
• Device Sequence Number: 6964068
• Product Code: OYE
• UDI-Device Identifier: 00382906628787
• UDI-Public: (01)00382906628787(11)180426
• 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: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/27/2024

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: 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: 07/19/2024
• Supplement Date Received by Manufacturer: 07/19/2024; 09/27/2024
• Initial Report FDA Received Date: 08/13/2024
• Supplement Report FDA Received Date: 08/27/2024; 09/30/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/26/2018
• 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