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 Problems No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 10/06/2020

Event Type  malfunction  

Manufacturer Narrative

Date of event: unknown.The date received by manufacturer has been used for this field.Medical device expiration date: unknown a device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, (b)(4).

Event Description

It was reported that waste leakage occurred outside of instrument with a bd facs sample prep assistant ii.The following information was provided by the initial reporter: it was reported that wash tower is overflowing.Was the leak contained within the instrument? no was the leak in a customer accessible location? yes what was the fluid that leaked? waste what is the source of leak -- waste line or non-waste line? waste was the customer exposed to blood or bodily fluids? no was there any physical harm to the customer as a result of the leak? no.

Manufacturer Narrative

Investigation summary : (b)(4), pn: 337170, spaii, sn: (b)(6) date reported: 10/06/2020.Investigation summary: scope of issue: the scope of issue is limited to part: 337170 ,spaii, and serial number: (b)(6).Problem statement: customer reported the spaii initialization error and wash tower overflowing.Manufacturing defect trend: there are 0 qns related to the reported issue.Date range (date of incident to 12 months back) from 06oct2019 to date 06oct2020 (rolling 12 months).Complaint trend:there are 5 complaints related to the reported ¿initialization error¿ complaint.Date range (date of incident to 12 months back) from 06oct2019 to date 06oct2020 (rolling 12 months).Related complaint(s) number: (b)(4) (this complaint).Complaint trend:there are 4 complaints related to the reported ¿wash tower overflowing¿ complaint.Date range (date of incident to 12 months back) from 06oct2019 to date 06oct2020 (rolling 12 months).Related complaints: (b)(4) (this complaint).Investigation result / analysis: per fse report: initialization error could not be reproduced.Verified wash tower overflow caused by clogged fitting on the in-line filter.Replaced the clogged fitting on the filter.Verified proper aspiration of fluid from the wash tower.Ran a total of approximately 120 tubes, power cycled and initialized the instrument multiple time and encountered no errors.Service max review: review of related work order #01635147.Install date: (b)(6) 2005, defective part number: there were no defective parts.Work order notes: subject / reported: instrument initialization error and wash tower overflowing.Problem description: wash tower overflow.Cause: cannot duplicate initialization error.Clogged fitting caused overflow.Work performed: replaced fittings.Solution: replaced fittings.Returned sample evaluation: there were no defective parts.Manufacturing device history record (dhr) review: review of the dhr for serial number: (b)(6) was reviewed.The instrument met all the manufacturing specifications prior to release.Risk analysis: risk management file part #(b)(4), revision 02 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: alarp, mitigation(s) sufficient yes/no.Root cause: based on the investigation result, and the fse¿s report the root cause could not be determined for the initialization error.Clogged fitting caused the wash tower to overflow.Conclusion: based on the investigation results and the fse report the complaint was unconfirmed for the wash tower overflow.

Event Description

It was reported that waste leakage occurred outside of instrument with a bd facs sample prep assistant ii.The following information was provided by the initial reporter: it was reported that wash tower is overflowing.Was the leak contained within the instrument? no.Was the leak in a customer accessible location? yes.What was the fluid that leaked? waste.What is the source of leak -- waste line or non-waste line? waste.Was the customer exposed to blood or bodily fluids? no.Was there any physical harm to the customer as a result of the leak? 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
• MDR Report Key: 10741398
• MDR Text Key: 214786993
• Report Number: 2916837-2020-00212
• Device Sequence Number: 1
• Product Code: JQW
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other,user facility
• Type of Report: Initial,Followup
• Report Date: 04/06/2021

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?: No
• Initial Date Manufacturer Received: 10/06/2020
• Initial Date FDA Received: 10/27/2020
• Supplement Dates Manufacturer Received: 04/06/2021
• Supplement Dates FDA Received: 04/06/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1