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

Model Number	647205
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/07/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that while using the bd facs¿ sample prep assistant iii that the wash station is overflowing.The following information was provided by the initial reporter: wash station is overflowing.They cleaned the in-line filter but it did not help.
Additional Manufacturer Narrative
Common device name: automated pipetting, diluting and specimen processing workstations for flow cytometric analysis.A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.
Additional Manufacturer Narrative
H.6 investigation summary (b)(4) pn: 647205 spaiii sn: (b)(6) awareness: 11/07/2022 opened: 11/07/2022 ¿ investigation summary: ¿ scope of issue: the scope of issue is limited to part: 647205 spaiii and serial number: (b)(6) ¿ problem statement: customer reported: wash station is overflowing ¿ manufacturing defect trend: there are 0 qns related to the reported issue.Date range (date of incident to 12 months back) from (b)(6) 2021 to date (b)(6) 2022 (rolling 12 months) ¿ complaint trend: there are 13 complaints related to the reported complaint.Date range (date of incident to 12 months back) from (b)(6) 2021 to date (b)(6) 2022 (rolling 12 months) o complaint data attached ¿ investigation result / analysis: per fse¿s report: verify problem.Removed, disassembled, cleaned and inspected in-line filter and fittings.No problem found.Upon observation, discovered that the sample probe had been slightly bent.Removed sample probe and tested to see if it was clogged.Probe was clogged.O located and installed new sample probe o tested and verified instrument performance o no further issues o sample preparation was not affected.O there was no delay in patient treatment due to any unexpected results.¿ service max review: review of related work order#: wo - (b)(4) install date: (b)(6) 2011.Defective part number: part number not reported.Work order notes: o subject / reported: wash station is overflowing o problem description: wash station is overflowing o cause: bent/clogged probe o work performed: replaced probe o solution: replaced probe o parts replaced: probe (part number not reported) ¿ returned sample analysis: the defective part was not requested to be returned and no photo(s) / picture(s) were provided ¿ manufacturing device history record (dhr) review: review of the dhr for serial number: (b)(6) and (b)(4) was reviewed.The instrument met all the manufacturing specifications prior to release.¿ risk analysis: risk management file part #100245ra, revision 03 was reviewed.Hazard(s) identified? yes no hazard id: 3.1.29 hazard: environment biohazard cause: filter/components in fluid path get clogged harmful effects: exposure to biohazard residual severity: 5 residual probability: 1 residual risk index: 5 ¿ root cause: based on the investigation result and fse¿s report the root cause was by bent/clogged probe ¿ conclusion: based on the investigation results and the fse¿s report the complaint was confirmed for wash station is overflowing.No one was harmed or injured, and no medical diagnosis was performed due to any incorrect results.There was no impact to the patient health or safety.H3 other text : see h.10.
Event or Problem Description
It was reported that while using the bd facs¿ sample prep assistant iii that the wash station is overflowing.The following information was provided by the initial reporter: wash station is overflowing.They cleaned the in-line filter but it did not help.

• 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: phillip emmert ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 15798140
• Report Number: 2916837-2022-00345
• Device Sequence Number: 4546413
• Product Code: PER
• UDI-Device Identifier: 00382906472052
• UDI-Public: 00382906472052
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• 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: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/14/2023

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 Model Number: 647205
• 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: 11/07/2022
• Supplement Date Received by Manufacturer: 02/14/2023
• Initial Report FDA Received Date: 11/15/2022
• Supplement Report FDA Received Date: 02/16/2023
• 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