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

Catalog Number	662875
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	02/04/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that sample carryover was observed during use with the bd facslyric.The following information was provided by the initial reporter: mdr safety checklist : contamination : 1.Were patient samples contaminated or was there carryover (cross-contamination/mixing) between patient samples? if no, no further questions required.Patient samples contaminated, carryover between patient samples, unknown ¿ go to question #2.: carryover between patient samples.2.Please describe any additional details: go to patient samples checklist: backflush/sample carryover in the water tube with residual blood.Backflush/sample carryover in the water tube with residual blood after shutdown yesterday.It happens when the machine is sitting idle and blood can be seen in tube on the sit.
Additional Manufacturer Narrative
D.4.Medical device expiration date: na.H.3.A device evaluation and/or device history review is anticipated but is not complete.Upon completion, a supplemental report will be filed.
Additional Manufacturer Narrative
H.6.Investigation summary: based on the investigation results, the reported issue of the customer experiencing carryover was confirmed.Investigation results that were performed on the indicated failure mode were the following: the complaint trend, device history record (dhr), and service notes were reviewed.The potential cause for the customer experiencing carryover was due to kinked tubing.Tubing was replaced, the waste tubing was rearranged and long clean was performed.No further problems were noted, and the instrument was confirmed to be functioning as expected.Although the instrument was used for diagnostic testing, the issue was resolved before the patient sample results were used for any diagnosis or treatment.
Event or Problem Description
It was reported that sample carryover was observed during use with the bd facslyric.The following information was provided by the initial reporter: mdr safety checklist : contamination : 1.Were patient samples contaminated or was there carryover (cross-contamination/mixing) between patient samples? if no, no further questions required.Patient samples contaminated, carryover between patient samples, unknown ¿ go to question #2.: carryover between patient samples.2.Please describe any additional details: go to patient samples checklist: backflush/sample carryover in the water tube with residual blood.Backflush/sample carryover in the water tube with residual blood after shutdown yesterday.It happens when the machine is sitting idle and blood can be seen in tube on the sit.

• Brand Name: BD FACSLYRIC
• Common Device Name: FLOW CYTOMETRIC REAGENTS AND ACCESSORIES
• 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: 21446077
• Report Number: 3027394506-2025-00005
• Device Sequence Number: 7290666
• Product Code: OYE
• UDI-Device Identifier: 00382906628756
• UDI-Public: (01)00382906628756(11)210722
• Combination Product (Y/N): N
• Initial Reporter State: OH
• 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): 03/25/2025

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: 02/05/2025
• Supplement Date Received by Manufacturer: 03/25/2025
• Initial Report FDA Received Date: 02/24/2025
• Supplement Report FDA Received Date: 03/26/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/22/2021
• 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