MAUDE Adverse Event Report: BECTON, DICKINSON AND COMPANY, BD BIOSCIENCES BD FACSLYRIC¿; SEE H.10

Model Number	663518
Medical Device Problem Code	Contamination (1120)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/28/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
D.3 common device name: flow cytometric reagents and access.E.7 initial reporter addr 1: clm bldg rm c1-011-ci 327 e 64th st new york 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¿ that there was carryover involving patient samples.The following information was provided by the initial reporter: customer believes there is carryover and waiting for a bd action, we can not just move to ep then close ep before closing the loop with the customer.Clinical apps still needs to determine if carryover is present- field service does not complete this.
Additional Manufacturer Narrative
H.6 investigation summary: ¿ scope of issue: the scope of issue is only limited to facslyric 3l12c instrument usivd, part # 663518, serial # (b)(6).¿ problem statement: the customer reported a complaint regarding carryover that occurred on (b)(6) 2023.Carryover poses the risk of producing erroneous results that might impact patient diagnosis and treatment.The investigation was performed and the instrument was found to be functioning as expected.No customers or patients were harmed due to this issue.¿ manufacturing defect trend: there are 0 qns (quality notifications) related to the reported issue for part # 663518.Date range from (b)(6) 2022 to date (b)(6) 2023.¿ manufacturing device history record (dhr) review: dhr part # 663518, serial # (b)(6), file # (b)(4) was reviewed.The instrument met all the manufacturing specifications prior to release.Date of manufacture: (b)(6) 2022 ¿ complaint history review: there are 10 complaints related to the reported issue with the as reported code 1: ¿contamination - carry over¿ and as analyzed code 1: ¿no findings available¿ for part # 663518.Pr # (b)(4).Date range from (b)(6) 2022 to date (b)(6) 2023.¿ returned sample analysis: a return sample was not requested for evaluation because no parts were replaced.¿ service history review: review of related work order install date: (b)(6) 2022 defective part number: n/a summary of work order notes: o sample carryover reported by customer o no work performed as investigation by clinical applications team is required to determine if carryover is present o carryover levels can be impacted if samples greater than 0.5 ml are run.The lab has a workaround in place to keep sample carryover to a moderate level.Ep-0278 notes: o project name: lyric sit drip/carryover o 25oct2023 (latest update): new valve reliability tests have been successfully completed.Test summary and performance confirmation to be completed to confirm no aging/wearing issues.Characterization and v&v protocols are being created.Project is estimated to end by march 2024.¿ risk review: risk management file part # 10000063058ra, rev.08/vers.Ab, bd facslyric system risk analysis was reviewed.No new hazards have been identified and the current mitigations are sufficient.Hazard(s) identified? ¿yes ¿no o azure id: (b)(6) o hazard id #: (b)(6) o hazard: incorrect output for samples up to 1.5ml or less.O cause: sample carryover error - fluidic.O harmful effects: events appear in wrong tube (false positive result).O residual probability: 1 o residual severity: 3 o residual risk index: 3 ¿ potential causes: based on the investigation results, the potential cause of carryover could not be determined.¿ investigation result / analysis: the investigation was performed and based on the review of the complaint trend, defect trend, dhr, risk analysis, and servicemax review, the potential cause could not be determined.The customer reported a complaint regarding carryover.In servicemax case # (b)(4), the fse documented the issue and created an escalation-type work order where the investigation was deferred to the clinical applications team to help determine if carryover was present.Bd reached out to the customer regarding testing carryover protocol.However, the customer was not open to testing the instrument and they were not concerned about carryover.At this time, the instrument is considered to be functioning as expected.This case is linked to an ep (escalation project), ep-0278 - lyric sit drip/carryover, that was opened to investigate recurring issues of carryover/sit drips on facslyric instruments.Ep-0278 will document details of this investigation and next steps taken to resolve the issue, as well as any cases/work orders on this issue.This issue did not produce any unexpected or erroneous results on patient samples.No patients or users were harmed due to this issue.Per the servicemax case comments ¿ ¿per ifu carryover performance can be affected if running more than 0.5 ml.Customer has implemented work around of wiping the sit¿.Proper daily and monthly cleaning procedures can be found under ¿maintenance¿ in the user guide; bd facslyric¿ clinical system instructions for use, #23-19938-02 rev.01/vers.A, page 165.The safety risk of this hazard has been identified to be within the acceptable level.¿ conclusion: based on the investigation results, the complaint was confirmed and the potential cause of the carryover could not be determined.The customer reported a complaint regarding carryover, which required investigation by the clinical applications team.The customer declined further testing and is not concerned about carryover.Therefore, the instrument is considered to be operating properly.No one was harmed or injured due to this issue, and the safety risk of this hazard has been identified to be within the acceptable level.¿ supporting document: n/a h3 other text : see h.10.
Event or Problem Description
It was reported that while using bd facslyric¿ that there was carryover involving patient samples.The following information was provided by the initial reporter: customer believes there is carryover and waiting for a bd action, we can not just move to ep then close ep before closing the loop with the customer.Clinical apps still needs to determine if carryover is present- field service does not complete this.

• Brand Name: BD FACSLYRIC¿
• Common Device Name: SEE H.10
• 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: phillip emmert ; 5859 farinon drive; san antonio, TX 78249 ; 8448235433
• MDR Report Key: 16817183
• Report Number: 2916837-2023-00099
• Device Sequence Number: 19293339
• Product Code: OYE
• UDI-Device Identifier: 00382906635181
• UDI-Public: 00382906635181
• 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): 11/29/2023

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 Model Number: 663518
• 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: 03/28/2023
• Supplement Date Received by Manufacturer: 11/29/2023
• Initial Report FDA Received Date: 04/26/2023
• Supplement Report FDA Received Date: 11/29/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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