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	04/07/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during use with the bd facs¿ lyse wash assistant, carryover between patient samples was observed.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.
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
The following fields have been updated with corrected information.Annex g: g04034 - connector/coupler.H.6 investigation summary: based on the investigation results, the issue 'cross contamination' was confirmed, the cause of the complaint was a clogged restrictor.The customer reported cross contamination on their instrument and a field service engineer (fse) was sent onsite to observe the issue.The (fse) confirmed that the cell wash pipette was not being flushed between each tube and replaced the restrictor.The fse then tested the instrument and confirmed that it was functioning per bd specifications.There was no impact to customer or patient safety due to this event.A return sample was not requested for evaluation as the root cause of the issue was identified without requiring a sample analysis.4 complaints regarding similar issues regarding clogs resulting in carryover were identified within 12 months of this event.Device history review (dhr) review was not required as the root cause was identified in the field.
Event or Problem Description
It was reported that during use with the bd facs¿ lyse wash assistant, carryover between patient samples was observed.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.

• 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: 21881859
• Report Number: 3027394506-2025-00018
• Device Sequence Number: 8631484
• Product Code: JQW
• UDI-Device Identifier: 00382903371464
• UDI-Public: (01)00382903371464(11)160402
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• 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: Foreign,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/23/2025

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: 04/07/2025
• Supplement Date Received by Manufacturer: 07/23/2025
• Initial Report FDA Received Date: 04/22/2025
• Supplement Report FDA Received Date: 07/25/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/02/2016
• 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