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 Codes	Contamination (1120); Incorrect, Inadequate or Imprecise Result or Readings (1535)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/22/2025
Type of Reportable Event	Malfunction
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.
Event or Problem Description
It was reported that during use with the bd facs¿ lyse wash assistant, carryover was observed on patient samples.No patient impact was identified.The following information was provided by the initial reporter: we suspect carry over between samples in the lwa.We have experienced ¿unexpected¿ sick cells in two different samples on two different days.Once we repeat the samples, we no longer see the ¿unexpected¿ cells.In both samples the preparation was performed on the lwa and in both cases other samples were processed (washed and lysed) in a row in carousel in the lwa.It was also common between the two samples with ¿unexpected¿ cells that the sample just before in the row in lwa contained high number of sick cells.The immunoprofile of the sick cells correspond to the ¿unexpected¿ cells.We therefore tested the hypothesis of carry over.We do see carry over of sick unexpected cells between samples.In this case we had placed four tubes in the lwa: sick ¿ healthy ¿ sick- healthy.We washed and lysed the samples according to the schedule below: test 1: we observed 26 sick cells out of a total of 99.414 cells = carry over of (b)(4).Test 2: we observe 39 sick cells out of total of 100.630 cells= carry over of (b)(4).According to the tech specs the expected carry over is (b)(4).
Additional Manufacturer Narrative
The following field has been updated with corrected information: h.6 imdrf annex a code - a1801.H.6 investigation summary: based on the investigation results, the reported issue of the customer experiencing carryover for patient id: (b)(6) occurring on (b)(6) 2025 was confirmed.Investigation results that were performed on the indicated failure mode were the following: the complaint trend and service notes were reviewed.The potential cause for the customer experiencing carryover due to the cell wash assembly.The issue was resolved after the flushing block in the cell wash assembly was adjusted and a 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 during use with the bd facs¿ lyse wash assistant, carryover was observed on patient samples.No patient impact was identified.The following information was provided by the initial reporter: we suspect carry over between samples in the lwa.We have experienced ¿unexpected¿ sick cells in two different samples on two different days.Once we repeat the samples we no longer see the ¿unexpected¿ cells.In both samples the preparation was performed on the lwa and in both cases other samples were processed (washed and lysed) in a row in carousel in the lwa.It was also common between the two samples with ¿unexpected¿ cells that the sample just before in the row in lwa contained high number of sick cells.The immunoprofile of the sick cells correspond to the ¿unexpected¿ cells.We therefore tested the hypothesis of carry over.We do see carry over of sick unexpected cells between samples.In this case we had placed four tubes in the lwa: sick ¿ healthy ¿ sick- healthy we washed and lysed the samples according to the schedule below: test 1: we observed 26 sick cells out of a total of 99.414 cells = carry over of 0,03% test 2: we observe 39 sick cells out of total of 100.630 cells= carry over of 0,04 % according to the tech specs the expected carry over is 0,005%.

• 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: 22204571
• Report Number: 3027394506-2025-00027
• Device Sequence Number: 18059339
• Product Code: JQW
• UDI-Device Identifier: 00382903371464
• UDI-Public: (01)00382903371464(11)241016
• Combination Product (Y/N): N
• Initial Reporter Country: DA
• 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): 01/07/2026

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: 05/28/2025
• Supplement Date Received by Manufacturer: 07/18/2025
• Initial Report FDA Received Date: 06/13/2025
• Supplement Report FDA Received Date: 01/08/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/16/2024
• 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