MAUDE Adverse Event Report: BECTON, DICKINSON AND COMPANY, BD BIOSCIENCES BD FACS¿ SAMPLE PREP ASSISTANT III; SEE H.10

Catalog Number	647205
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	10/09/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that carryover was observed on patient samples during use with the bd facs¿ sample prep assistant iii.The following information was provided by the initial reporter: in "wo-03192403" it has been stated as "sample carryover in pipetting" as part of compliance review could you please answer the following safety questions 1.Was the carryover observed in patient samples? a: yes, it was observed in patient samples.System pipetting failure.
Additional Manufacturer Narrative
D.2.Common device name:: automated pipetting, diluting and specimen processing workstations for flow cytometric analysis d.4.Medical device expiration date: na.E.1.(b)(6).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 and/or additional information: reporting office contact: fahmy razak - mdr.Manufacturing site contact: fahmy razak - mdr.H.6: based on the investigation results, the reported issue "system pipetting failure" was confirmed.Investigation results that were performed on the indicated failure mode were the following: the device history record (dhr) was reviewed and the product met all manufacturing specifications prior to release.The potential cause was due to a misaligned probe which was replaced, and subsequent tests were carried out with no issues observed.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 carryover was observed on patient samples during use with the bd facs¿ sample prep assistant iii.The following information was provided by the initial reporter: in "(b)(4)" it has been stated as "sample carryover in pipetting" as part of compliance review could you please answer the following safety questions 1.Was the carryover observed in patient samples? a: yes, it was observed in patient samples.System pipetting failure.

• Brand Name: BD FACS¿ SAMPLE PREP ASSISTANT III
• Common Device Name: SEE H.10
• 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: 18539507
• Report Number: 2916837-2024-00001
• Device Sequence Number: 6402152
• Product Code: PER
• UDI-Device Identifier: 00382906472052
• UDI-Public: 00382906472052
• Combination Product (Y/N): N
• Initial Reporter Country: CO
• PMA/510(K) Number: K131301
• 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): 03/22/2024

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: 647205
• 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: 01/09/2024
• Supplement Date Received by Manufacturer: 03/22/2024
• Initial Report FDA Received Date: 01/18/2024
• Supplement Report FDA Received Date: 03/26/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/22/2012
• 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