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

Catalog Number	662875
Medical Device Problem Code	Contamination (1120)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/20/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during use with a bd facslyric¿ instrument carryover occurred and a false positive result was obtained on patient samples.There was no report of patient impact.The following information was provided by the initial reporter: we are getting carry over from one sample to the next.If the first sample is positive and the second sample is to be negative, it is coming up positive from cell infiltrates from the positive first tube.
Additional Manufacturer Narrative
G.5.Additional pma / 510(k)#: bk230835, k170974, h.3.A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.
Additional Manufacturer Narrative
H.6.Investigation summary: based on the investigation results, the cause of the complaint was confirmed to be due to a damaged waste tubing.The customer initially reported carryover observed on this instrument and a bd field service engineer was sent onsite to address the issue.The fse identified that the orange waste fitting was damaged and trimmed off the damaged portion.They then reassembled the sit mount, reinstalled onto the instrument, and confirmed that the instrument was functioning as expected per bd specifications.No one was harmed or injured, and there was no impact to patient diagnosis or treatment.A return sample was not requested for evaluation as the root cause of the issue was identified without requiring a sample analysis.Two other complaints were identified with carryover due to damaged tubing.
Event or Problem Description
It was reported that during use with a bd facslyric¿ instrument carryover occurred and a false positive result was obtained on patient samples.There was no report of patient impact.The following information was provided by the initial reporter: we are getting carry over from one sample to the next.If the first sample is positive and the second sample is to be negative, it is coming up positive from cell infiltrates from the positive first tube.

• Brand Name: BD FACSLYRIC¿ INSTRUMENT
• Common Device Name: FLOW CYTOMETRIC REAGENTS AND ACCESS
• Manufacturer (Section D): BECTON, DICKINSON AND COMPANY, BD BIOSCIENCES; 155 north mccarthy boulevard; milpitas CA 95035
• Manufacturer (Section G): BECTON, DICKINSON AND COMPANY, BD BIOSCIENCES; 155 north mccarthy boulevard; milpitas CA 95035
• Manufacturer Contact: fahmy razak - mdr ; 155 north mccarthy boulevard; milpitas, CA 95035 ; 8772328995
• MDR Report Key: 21868586
• Report Number: 3027394506-2025-00016
• Device Sequence Number: 14632649
• Product Code: OYE
• UDI-Device Identifier: 00382906628756
• UDI-Public: (01)00382906628756(11)210326
• Combination Product (Y/N): N
• Initial Reporter State: LA
• 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
• Report Date (Section B): 05/16/2025

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: 662875
• 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: 03/20/2025
• Supplement Date Received by Manufacturer: 05/16/2025
• Initial Report FDA Received Date: 04/18/2025
• Supplement Report FDA Received Date: 05/16/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/26/2021
• 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