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	08/02/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that carryover was observed on patient samples during use with the bd facslyric¿.The following information was provided by the initial reporter: patient sample checklist: are there erroneous results on patient samples from diagnostic test? no.Called and spoke with customer and customer stated that they were patient samples but they detected the issue right away and stopped using this lyric.No false results were reported to patients or doctors as a result of this issue.It was reported by the customer that carry over of samples.Sit flush may not be functioning properly.No false resolves were reported to patients or doctors.
Additional Manufacturer Narrative
D.4.Medical device expiration date: na.G.5.Pma / 510(k)#: k170974 g.5.Pma / 510(k)#: k201814.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 on patient samples during use with the bd facslyric¿.The following information was provided by the initial reporter: patient sample checklist: are there erroneous results on patient samples from diagnostic test? no.Called and spoke with customer and customer stated that they were patient samples but they detected the issue right away and stopped using this lyric.No false results were reported to patients or doctors as a result of this issue.It was reported by the customer that carry over of samples.Sit flush may not be functioning properly.No false resolves were reported to patients or doctors.
Additional Manufacturer Narrative
The following fields have been updated: g.1.Reporting office: becton dickinson and company bd biosciences.G.2.Reporting office contact: (b)(6) - mdr.G.4.Manufacturing site contact: (b)(6) - mdr.H.6.Investigation summary: based on the investigation results, the complaint was confirmed and the potential cause of the customer experiencing carryover issues on the facslyric was determined to be plugged sit assembly.Fse performed system checks including a sit flush, p2 and v8 assembly.Fse then removed and cleaned& flushed the sit assembly.Afterwards, the instrument is functioning as expected.No one was harmed or injured, and no medical diagnosis was performed due to any incorrect results.The safety risk of this hazard has been identified to be within the acceptable level.Complaints received for this device will continue to be tracked and trended.Information will be captured on trend reports and monitored to determine if further action is needed.Our business team regularly reviews the collected data for identification of emerging trends.H3 other text : see h.10.

• 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: 17637991
• Report Number: 2916837-2023-00172
• Device Sequence Number: 6481224
• Product Code: OYE
• UDI-Device Identifier: 00382906628787
• UDI-Public: 00382906628787
• Combination Product (Y/N): N
• Initial Reporter State: KY
• Initial Reporter Country: US
• PMA/510(K) Number: SEE H.10
• 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): 03/02/2024

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: 08/02/2023
• Supplement Date Received by Manufacturer: 03/01/2024
• Initial Report FDA Received Date: 08/28/2023
• Supplement Report FDA Received Date: 03/06/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/03/2017
• 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