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 01/17/2023

Event Type  malfunction  

Event Description

It was reported that during use with the bd facs¿ sample prep assistant iii that leakage under pressure occurred outside of the instrument.The following information was provided by the initial reporter: it was reported by the customer that instrument is not pipetting properly.(b)(6) 2023, 20:09:49 (gmt).Caller reports that the blood is splattered inside the tubes and some inside the machine, no aspiration.

Manufacturer Narrative

Common device name: automated pipetting, diluting and specimen processing workstations for flow cytometric analysis.Initial reporter facility name: (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 during use with the bd facs¿ sample prep assistant iii that leakage under pressure occurred outside of the instrument.The following information was provided by the initial reporter: it was reported by the customer that instrument is not pipetting properly.(b)(4) : 2023-01-17 20:09:49 (gmt).Caller reports that the blood is splattered inside the tubes and some inside the machine - no aspiration.

Manufacturer Narrative

H.6 investigation summary: (b)(4), pn: 647205 spaiii, sn: (b)(6), awareness: 01/17/2023, opened: 01/17/2023.Scope of issue: the scope of issue is limited to part: 647205 spaiii and serial number: (b)(6).Problem statement: customer reported: not pipetting properly.Manufacturing defect trend: there are 0 qns related to the reported issue.Date range (date of incident to 12 months back) from 17jan2022 to date 17jan2023 (rolling 12 months).Complaint trend: there is 1 complaint related to the reported complaint.Date range (date of incident to 12 months back) from 17jan2022 to date 17jan2023 (rolling 12 months) (b)(4) (this complaint).Investigation result / analysis: per fse¿s report: tightened all connections on valves.Had customer test with samples.No further issues sample preparation was not affected.There was no delay in patient treatment due to any unexpected results.Service max review: review of related work order#: (b)(4).Install date: 06jul2010.Defective part number: there were no defective parts.Work order notes: subject / reported: not pipetting properly.Problem description: not aspirating.Cause: valve connection.Work performed: tightened valve connections.Solution: tightened valve connections.Parts replaced: no parts were replaced.Returned sample analysis: there were no defective parts.Manufacturing device history record (dhr) review: review of the dhr for serial number: (b)(6) and pn647205 was reviewed.The instrument met all the manufacturing specifications prior to release.Risk analysis: risk management file part #(b)(4), revision 03 was reviewed.Hazard(s) identified? ¿yes ¿no.¿ hazard id: (b)(4).¿ hazard: insufficient sample volume.¿ cause: probe does not aspirate enough volume for test.¿ harmful effects: incorrect or no result.¿ residual severity: 2.¿ residual probability: 2.¿ residual risk index: 4.Potential causes: based on the investigation result and fse¿s report the potential cause was determined to loosen valve connection.Conclusion: based on the investigation results and the fse¿s report the complaint was confirmed for not pipetting properly.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: 16229114
• MDR Text Key: 309094496
• Report Number: 2916837-2023-00010
• 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: Other,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 03/29/2023

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: 01/17/2023
• Initial Date FDA Received: 01/23/2023
• Supplement Dates Manufacturer Received: 03/29/2023
• Supplement Dates FDA Received: 04/05/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/22/2012
• 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