MAUDE Adverse Event Report: BECTON DICKINSON AND COMPANY BD BIOSCIENCES BD FACSLYRIC¿; COUNTER, DIFFERENTIAL CELL

Catalog Number	662878
Medical Device Problem Code	Contamination of Device Ingredient or Reagent (2901)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/26/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
G.5 pma / 510(k)#: k170974, k201814 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¿ flow cytometer carryover occurred.There was no report of user impact.The following information was provided by the initial reporter: "it was reported by the customer that seeing patients cell population when run a tube with only pbs after the patient sample/bd fse is onsite already and working on crossover 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 while using bd facslyric¿ flow cytometer carryover occurred.There was no report of user impact.The following information was provided by the initial reporter: "it was reported by the customer that seeing patients cell population when run a tube with only pbs after the patient sample/bd fse is onsite already and working on crossover issue.".
Event or Problem Description
It was reported that while using bd facslyric¿ flow cytometer carryover occurred.There was no report of user impact.The following information was provided by the initial reporter: "it was reported by the customer that seeing patients cell population when run a tube with only pbs after the patient sample/bd fse is onsite already and working on crossover issue.".
Additional Manufacturer Narrative
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 seeing patients cell population when run a tube with only pbs after the patient sample.The field service representative (fsr) performed a service visit.They verified the sit flush, replaced sample line with pn 652754.After the works performed, the customer repeated the assay and confirmed that carryover was no longer present.The instrument was confirmed to be performing according to specifications.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.

• Brand Name: BD FACSLYRIC¿
• Common Device Name: COUNTER, DIFFERENTIAL CELL
• 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: 19830877
• Report Number: 2916837-2024-00042
• Device Sequence Number: 7504861
• Product Code: OYE
• UDI-Device Identifier: 00382906628787
• UDI-Public: (01)00382906628787(11)240415
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: BK230835
• 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): 09/20/2024

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: 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: 06/27/2024
• Supplement Date Received by Manufacturer: 06/27/2024; 09/20/2024
• Initial Report FDA Received Date: 07/25/2024
• Supplement Report FDA Received Date: 08/27/2024; 09/24/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/15/2024
• 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