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
Additional Manufacturer Narrative
H.6 investigation summary: the investigation was performed and based on the review of the complaint trend, defect trend, device history review, risk analysis, and servicemax, the potential cause of carryover on the facslyric was determined to be a carryover issue from a partially clogged sample line tubing.The field service engineer confirmed the issue and replaced the sample line from a customer spare stock, reseated the valve v8 pinch tubing, and performed a flush to ensure proper flow and accuracy.No parts were requested for evaluation as there were no parts replaced.After the repair the instrument was tested and was performing 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.
Event or Problem Description
It was reported that during use of bd facslyric¿ carryover was observed.The following information was provided by the initial reporter: contamination: 1.Were patient samples contaminated or was their carryover (cross-contamination/mixing) between patient samples? carryover between patient samples.Customer problem: system is having issues with carryover between cells.
Event or Problem Description
It was reported that during use of bd facslyric¿ carryover was observed.The following information was provided by the initial reporter: contamination: 1.Were patient samples contaminated or was there carryover (cross-contamination/mixing) between patient samples? carryover between patient samples customer problem: system is having issues with carryover between cells.
Additional Manufacturer Narrative
D.4.Medical device expiration date: na.(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 during use of bd facslyric¿ carryover was observed.The following information was provided by the initial reporter: contamination: 1.Were patient samples contaminated or was there carryover (cross-contamination/mixing) between patient samples? carryover between patient samples.Customer problem: system is having issues with carryover between cells.
Additional Manufacturer Narrative
The following fields have been updated with corrected information.D.4.Unique identifier (udi) #:(b)(4).H.6 imdrf annex: b21.H.6 imdrf annex: c21.H.6 imdrf annex: d16.

• 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: 19579314
• Report Number: 2916837-2024-00037
• Device Sequence Number: 12892921
• Product Code: OYE
• UDI-Device Identifier: 00382906635181
• UDI-Public: (01)00382906635181(11)210511
• 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: Other,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: 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: 06/05/2024; 09/20/2024
• Initial Report FDA Received Date: 06/20/2024
• Supplement Report FDA Received Date: 08/27/2024; 09/23/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/11/2021
• 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