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

Model Number 647205

Device Problem Leak/Splash (1354)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 10/14/2022

Event Type  malfunction  

Manufacturer Narrative

Common device name: automated pipetting, diluting and specimen processing workstations for flow cytometric analysis initial reporter addr 1: (b)(6).A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.

Event Description

It was reported that while using the bd facs¿ sample prep assistant iii that there was leaking from the back of the instrument.The following information was provided by the initial reporter: leaking from back of instrument.

Event Description

It was reported that while using the bd facs¿ sample prep assistant iii that there was leaking from the back of the instrument.The following information was provided by the initial reporter: leaking from back of instrument.

Manufacturer Narrative

H.6 investigation summary (b)(4) pn: 647205 spaiii sn: (b)(6) awareness: 10/14/2022 opened: 10/14/2022 investigation summary: ¿ scope of issue: the scope of issue is limited to part: 647205 spaiii and serial number: (b)(6) ¿ problem statement: customer reported: leaking from back of instrument ¿ manufacturing defect trend: there are 0 qns related to the reported issue.Date range (date of incident to 12 months back) from 14oct2021 to date 14oct2022 (rolling 12 months) ¿ complaint trend: there are 11 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: cleaned filter on waste line.Replaced probe per customer request.Could not replicate issue.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: 30apr2018 defective part number: there were no defective parts work order notes: o subject / reported: leaking from back of instrument o problem description: could not replicate the issue o cause: cannot be determined o work performed: checked fluidic lines.Replaced probe o solution: could not replicate the issue o parts replaced: there were no defective parts ¿ returned sample analysis: there were no defective parts.¿ manufacturing device history record (dhr) review: review of the dhr for serial number: (b)(6) and (b)(6) was reviewed.The instrument met all the manufacturing specifications prior to release.¿ risk analysis: o risk management file part #100245ra, revision 03 was reviewed.O hazard(s) identified? yes no hazard id: (b)(4) 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 could not determined ¿ conclusion: based on the investigation results and the fse¿s report the complaint was unconfirmed for leaking from back of instrument.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.

• Brand Name: BD FACS¿ SAMPLE PREP ASSISTANT III
• Type of Device: 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: 15642978
• MDR Text Key: 307164287
• Report Number: 2916837-2022-00314
• Device Sequence Number: 1
• Product Code: PER
• UDI-Device Identifier: 00382906472052
• UDI-Public: 00382906472052
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K131301
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 03/27/2023

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
• Device Operator: Other
• Device Model Number: 647205
• Device Catalogue Number: 647205
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/14/2022
• Initial Date FDA Received: 10/20/2022
• Supplement Dates Manufacturer Received: 03/27/2023
• Supplement Dates FDA Received: 04/04/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/17/2017
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1