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

Catalog Number 650686

Device Problem Fluid/Blood Leak (1250)

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

Event Date 10/19/2022

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

It was reported that while using the bd facs¿ sample prep assistant that the instrument is overflowing fluid from the water tower.The following information was provided by the initial reporter: it was reported by the customer over flowing fluid from water tower.

Event Description

It was reported that while using the bd facs¿ sample prep assistant that the instrument is overflowing fluid from the water tower.The following information was provided by the initial reporter: it was reported by the customer over flowing fluid - from water tower.

Manufacturer Narrative

H.6 investigation summary pr (b)(6) pn: (b)(6) spaiii sn: (b)(6) awareness: 10/19/2022 opened: 10/19/2022.Investigation summary: ¿ scope of issue: the scope of issue is limited to part: (b)(6) spaiii and serial number: (b)(6).¿ problem statement: customer reported: overflowing fluid ¿ from water tower ¿ manufacturing defect trend: there are (b)(4) 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 4 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 (this complaint).¿ investigation result / analysis: per fse¿s report: replaced filter waste fittings/coupling valves.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#: (b)(4) install date: (b)(6) 2009.Defective part number: 640520-coupling body valved, 640521-coupling insert valve work order notes: o subject / reported: overflowing fluid ¿ from water tower.O problem description: fluid leak.O cause: overflow caused by clogged coupling valves.O work performed: replaced coupling valves.O solution: replaced coupling valves.O parts replaced: 640520-coupling body valved, 640521-coupling insert valve.¿ returned sample analysis: the complaint sample 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 pn(b)(6) was reviewed.The instrument met all the manufacturing specifications prior to release.¿ risk analysis: o risk management file part #(b)(4), revision 03 was reviewed.O hazard(s) identified?: yes/no.O hazard id: 3.1.29.O hazard: environment biohazard.O cause: filter/components in fluid path get clogged.O harmful effects: exposure to biohazard.O residual severity: 5.O residual probability: 1.O residual risk index:: 5.¿ root cause: based on the investigation result and fse¿s report the root cause was clogged coupling valves.¿ conclusion: based on the investigation results and the fse¿s report the complaint was confirmed for overflowing fluid.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.

• Brand Name: BD FACS¿ SAMPLE PREP ASSISTANT
• 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: 15655056
• MDR Text Key: 302560680
• Report Number: 2916837-2022-00319
• Device Sequence Number: 1
• Product Code: PER
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• 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: 01/20/2023

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 Catalogue Number: 650686
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/19/2022
• Initial Date FDA Received: 10/21/2022
• Supplement Dates Manufacturer Received: 01/20/2023
• Supplement Dates FDA Received: 01/25/2023
• 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