MAUDE Adverse Event Report: BECTON, DICKINSON AND COMPANY, BD BIOSCIENCES BD FACS SAMPLE PREP ASSISTANT II; STATION, PIPPETTING DILUTING CLINICAL

Catalog Number 337170

Device Problem Fluid/Blood Leak (1250)

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

Event Date 05/10/2022

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.¿.

Event Description

It was reported that while using bd facs sample prep assistant ii the wash station overflows.The following information was provided by the initial reporter: was the leak liquid or air? liquid.Was the leak contained within the instrument? not contained.Was there spray of liquid under pressure? no.What was the fluid that leaked? biohazard.Did biohazard leak before or after waste line? after waste line.Was the waste mixed with decontamination/bleach? no.Was the customer/bd personnel physically in contact with the fluid? no.

Manufacturer Narrative

After further evaluation of the complaint, it has been determined that the previously submitted mfr report# 2916837-2022-00122 was sent in error.It was discovered that the customer reported that the leakage was contained within the instrument, therefore, this is not considered to be a reportable malfunction.

Event Description

It was reported that while using bd facs sample prep assistant ii the wash station overflows.The following information was provided by the initial reporter: 1) was the leak liquid or air? liquid.2) was the leak contained within the instrument? not contained.3) was there spray of liquid under pressure? no.4) what was the fluid that leaked? biohazard.5) did biohazard leak before or after waste line? after waste line.6) was the waste mixed with decontamination/bleach? no.7) was the customer/bd personnel physically in contact with the fluid? no.

Manufacturer Narrative

The following fields have been updated with additional information: d.9.Device available for eval? yes d.9 returned to manufacturer on: 13-may-2022.H.2 device eval by manufacturer?: yes.Investigation summary: scope of issue: the scope of issue is limited to part: 337170 spaii and serial number: (b)(6).Problem statement: customer reported: wash tower overflows.Manufacturing defect trend: there are 0 qns related to the reported issue.Date range (date of incident to 12 months back) from 10may2021 to date 10may2022 (rolling 12 months).Complaint trend: there are 6 complaints related to the reported complaint.Date range (date of incident to 12 months back) from 10may2021 to date 10may2022 (rolling 12 months) (b)(4).Investigation result / analysis: per fse report: repair/troubleshooting performed: found clog in mini wash pump and in-line filter assembly.Cleared clogs and primed system several times.Clog is cleared and instrument is performing as specified.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)(6).Install date: (b)(6) 2005.Defective part number: 640520-coupling body valve and 640521-coupling insert valve.Work order notes: subject / reported: wash tower overflows, problem description: clogged valves, cause: defective inline valves, work performed: replaced coupling valves, solution: replaced coupling valves.Returned sample evaluation: did not request return of defective part.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: environmental biohazard.Severity: 5.Probability: 1.Risk index: 5.Implementation: bd facs sample prep user¿s guide__.Risk control:_afap_____.Mitigation(s) sufficient yes no.Root cause: based on the investigation result and the fse¿s report the root cause was a clogged inline coupling valves.Conclusion: based on the investigation results and the fse¿s report the complaint was confirmed for wash tower overflowing.No one was harmed or injured, and no medical diagnosis was performed due to any incorrect results.The safety risk is limited, s2, and there was no impact to the patient health or safety.

Event Description

It was reported that while using bd facs sample prep assistant ii the wash station overflows.The following information was provided by the initial reporter: 1) was the leak liquid or air? liquid.2) was the leak contained within the instrument? not contained.3) was there spray of liquid under pressure? no.4) what was the fluid that leaked? biohazard.5) did biohazard leak before or after waste line? after waste line.6) was the waste mixed with decontamination/bleach? no.7) was the customer/bd personnel physically in contact with the fluid? no.

• Brand Name: BD FACS SAMPLE PREP ASSISTANT II
• Type of Device: STATION, PIPPETTING DILUTING CLINICAL
• 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: 14382907
• MDR Text Key: 291835560
• Report Number: 2916837-2022-00122
• Device Sequence Number: 1
• Product Code: JQW
• 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: Other,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 07/25/2022

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: 337170
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/10/2022
• Initial Date FDA Received: 05/12/2022
• Supplement Dates Manufacturer Received: 05/23/2022; 07/21/2022
• Supplement Dates FDA Received: 07/21/2022; 07/25/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/22/2022
• 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