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	07/27/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
E.1.Initial reporter phone#:(b)(6).D.4.Medical device expiration date: unknown.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.The following information was provide by the initial reporter: carry-over sometimes occurs after measuring large pathological populations.
Additional Manufacturer Narrative
The following fields have been updated with corrected information: reporting office and contact: (b)(6) manufacturing location: becton dickinson and company bd biosciences- san jose.Manufacturing site contact: (b)(4).H.6: based on the investigation, the complaint was confirmed.The potential cause was determined to be dirty needle and over needle.The fsr cleaned the needle and over needle and after subsequent trial runs with samples, the instrument was functioning as expected.No one was harmed or injured, and no patients were harmed from any erroneous results.The safety risk of this hazard has been identified to be within the acceptable level.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.
Event or Problem Description
It was reported that during use with the bd facs¿ lyse wash assistant, carryover was observed on patient samples.The following information was provide by the initial reporter: carry-over sometimes occurs after measuring large pathological populations.

• 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: 17499747
• Report Number: 2916837-2023-00164
• Device Sequence Number: 2394296
• Product Code: JQW
• UDI-Device Identifier: 00382903371464
• UDI-Public: 00382903371464
• Combination Product (Y/N): N
• Initial Reporter Country: AU
• PMA/510(K) Number: NA
• 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): 02/27/2024

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: 07/27/2023
• Supplement Date Received by Manufacturer: 02/27/2024
• Initial Report FDA Received Date: 08/10/2023
• Supplement Report FDA Received Date: 03/01/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/11/2019
• 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