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	04/23/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Date of event: unknown.The date received by manufacturer has been used for this field.Initial reporter phone #: (b)(6).Pma / 510(k)#: this device is currently listed as exempt for 510k.A device evaluation and/or device history review is anticipated but is not complete.Upon completion, a supplemental report will be filed.Device manufacture date: unknown.
Event or Problem Description
It was reported that while using bd lyse wash assistant experiences carryover issues.There was no report of user impact.The following information was provided by the initial reporter, translated from german to english: "we generally observe that cells are occasionally carried over into the lwas.".
Additional Manufacturer Narrative
The following fields have been updated with corrected information: d.4.Medical device serial #: (b)(6).D.4.Unique identifier (udi) #:(b)(4).H.4.Device manufacture date: 12-may-2023.H.6 imdrf annex b: b21.H.6 imdrf annex c: c21.H.6 imdrf annex d: d16.
Event or Problem Description
It was reported that while using bd lyse wash assistant experiences carryover issues.There was no report of user impact.The following information was provided by the initial reporter, translated from german to english: "we generally observe that cells are occasionally carried over into the lwas.".
Additional Manufacturer Narrative
Based on the investigation results, the reported issue of carryover due to sample splatter on the carousel rack was not confirmed.The potential cause could not be determined.The fse performed a series of tests on the instrument and could not reproduce the error or confirm the carryover issue, and the instrument was returned to operational status.This issue did not impact patient diagnosis or treatment and no user or patient was harmed or injured.The complaint sample was not requested to be returned because no parts were replaced.Review of the dhr confirmed that the instrument met all the manufacturing specifications prior to release.
Event or Problem Description
It was reported that while using bd lyse wash assistant experiences carryover issues.There was no report of user impact.The following information was provided by the initial reporter, translated from german to english: "we generally observe that cells are occasionally carried over into the lwas.".

• 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: 19375799
• Report Number: 2916837-2024-00032
• Device Sequence Number: 7509848
• Product Code: JQW
• UDI-Device Identifier: 00382903371464
• UDI-Public: (01)00382903371464(11)230512
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: SEE H.10
• 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): 09/25/2024

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: 04/23/2024
• Supplement Date Received by Manufacturer: 04/23/2024; 04/23/2024
• Initial Report FDA Received Date: 05/22/2024
• Supplement Report FDA Received Date: 08/27/2024; 09/27/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/12/2023
• 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