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	Incorrect, Inadequate or Imprecise Result or Readings (1535)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/11/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during use with bd facs¿ lyse wash assistant carry over of patient samples occurred.There was no report of patient impact.The following information was provided by the initial reporter: the customer reported contamination issues: cells are transferred from one tube to the next.This could lead to miss interpretation of the results.
Additional Manufacturer Narrative
The following fields have been updated with corrected information: d.4.Unique identifier (udi) #: (b)(4).H.6 imdrf annex b: b21; h.6 imdrf annex c: c21; h.6 imdrf annex d: d16.
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 during use with bd facs¿ lyse wash assistant carry over of patient samples occurred.There was no report of patient impact.The following information was provided by the initial reporter: the customer reported contamination issues: cells are transferred from one tube to the next.This could lead to miss interpretation of the results.
Event or Problem Description
It was reported that during use with bd facs¿ lyse wash assistant carry over of patient samples occurred.There was no report of patient impact.The following information was provided by the initial reporter: the customer reported contamination issues: cells are transferred from one tube to the next.This could lead to miss interpretation of the results.
Additional Manufacturer Narrative
H6.Investigation summary: based on the investigation, the complaint contamination ¿ carryover was confirmed.Investigation results performed on the indicated failure mode were determined to be dirty/clogged v8 valve.The field service engineer replaced the v8 valve and cleanse pump, and after subsequent trial runs with samples, the instrument was functioning as expected.Complaints received for this device and reported condition will continue to be tracked and trended.Information will be captured on trend reports and monitored.Our business team regularly reviews the collected data for identification of emerging trends.

• Brand Name: BD FACS¿ LYSE WASH ASSISTANT
• Common Device Name: STATION, PIPETTING DILUTING CLINICAL USE
• Manufacturer (Section D): BECTON DICKINSON AND COMPANY BD BIOSCIENCES; 2350 qume drive; san jose CA 95131
• Manufacturer (Section G): BECTON, DICKINSON AND COMPANY, BD BIOSCIENCES; 2350 qume drive; san jose CA 95131
• Manufacturer Contact: fahmy razak - mdr ; 2350 qume drive; san jose, CA 95131 ; 4089542435
• MDR Report Key: 19706371
• Report Number: 2916837-2024-00038
• Device Sequence Number: 18080312
• Product Code: JQW
• UDI-Device Identifier: 00382903371464
• UDI-Public: (01)00382903371464(11)200917
• 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: Other,Foreign,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/20/2024

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: 06/24/2024
• Supplement Date Received by Manufacturer: 06/24/2024; 09/20/2024
• Initial Report FDA Received Date: 07/09/2024
• Supplement Report FDA Received Date: 08/23/2024; 09/23/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/17/2020
• 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