MAUDE Adverse Event Report: BECTON, DICKINSON AND COMPANY, BD BIOSCIENCES BD FACS¿ LYSE WASH ASSISTANT; STATION, PIPETTING DILUTING CLINICAL USE

Catalog Number	337146
Medical Device Problem Code	Contamination (1120)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/04/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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 facs¿ lyse wash assistant contaminated lines occurred.There was no report of patient impact.The following information was provided by the initial reporter: i am getting high background on all of my leukemia and lymphoma panels.I have isolated it to something on the lwa.The issue only happens when i run on the lwa.If i do a manual procedure everything works fine.Patient samples contaminated.
Event or Problem Description
It was reported that while using bd facs¿ lyse wash assistant contaminated lines occurred.There was no report of patient impact.The following information was provided by the initial reporter: i am getting high background on all of my leukemia and lymphoma panels.I have isolated it to something on the lwa.The issue only happens when i run on the lwa.If i do a manual procedure everything works fine.Patient samples contaminated.
Additional Manufacturer Narrative
The following field was updated with corrected information: h.6 annex g code: g04069 h.6 investigation summary: investigation executive summary: based on the investigation results, the reported issue of the customer experiencing high background on lymphoma panels was confirmed.Investigation results that were performed on the indicated failure mode were the following: -the complaint trend and service notes were reviewed.-review of the device history record (dhr).-conducted system calibration and testing the potential cause of high background on lymphoma panels was due to clogged and dirty fluidic lines where tubing and connectors needed to be replaced.Although the instrument was used for diagnostic testing, the issue was resolved before the patient sample results were used for any diagnosis or treatment.

• Brand Name: BD FACS¿ LYSE WASH ASSISTANT
• Common Device Name: STATION, PIPETTING DILUTING CLINICAL USE
• 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: 22399346
• Report Number: 3027394506-2025-00032
• Device Sequence Number: 4901857
• Product Code: JQW
• UDI-Device Identifier: 00382903371464
• UDI-Public: (01)00382903371464(11)191126
• Combination Product (Y/N): N
• Initial Reporter State: IA
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• 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): 08/06/2025

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: 337146
• 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: 06/19/2025
• Supplement Date Received by Manufacturer: 08/06/2025
• Initial Report FDA Received Date: 07/03/2025
• Supplement Report FDA Received Date: 08/06/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/26/2019
• 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