MAUDE Adverse Event Report: BECTON, DICKINSON AND COMPANY, BD BIOSCIENCES BD FACSVIA SYSTEM; FLOW CYTOMETRIC REAGENTS AND ACCESSORIES

Model Number	662386
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Codes	No Patient Involvement (2645); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/22/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Medical device expiration date: na.A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.(b)(4).
Event or Problem Description
It was reported while using bd facsvia¿ system waste leaked outside of instrument.There was no user impact.The following information was provided by the initial reporter: defective waste bottle.Steps taken with customer/troubleshooting: the customer reports that the tan quick connect on the waste bottle cap is broken, not allowing fluid to go into the tank and causing it to pool up on the cap.The instrument is down and out of service.They have samples that will keep over the weekend, but must be run on monday, so as a courtesy i am going to send her a new waste bottle (p/n 659605) so that they will not lose their samples.Are you using this product for clinical diagnostic test? yes.Were erroneous results reported and used to treat a patient? no.Was there any injury or potential injury? no.Resolution achieved? yes.Follow up required? yes.Was there a fluidic leak or spill? yes.Was the leak/spill contained within the instrument? no.Was the leak/spill in a customer accessible location? yes.What was the fluid that leaked/spilled? waste.What is the source of leak/spill (waste 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.Additionally, the fse provided the following additional information: the leaking waste was not mixed with bleach or a decontaminate at the point of the leak.
Additional Manufacturer Narrative
H6: investigation summary: scope of issue: the scope of issue is only limited to bd facsvia flow cytometer us, part # 662386 and serial # (b)(6).Problem statement: customer reported complaint on the defective waste bottle causing waste leakage without bleach outside of the instrument.Manufacturing defect trend: there are zero qns (quality notifications) related to the reported issue.Date range from 22jan2020 to 22jan2021.Complaint trend: there are 2 complaints related to the issue of waste tank leakage; date range from 22jan2020 to 22jan2021.Manufacturing device history record (dhr) review: dhr part # 662386 serial # (b)(6), file # (b)(4), was reviewed.The instrument met all the manufacturing specifications prior to release.Investigation result / analysis: the investigation was performed and based on the review of the complaint trend, defect trend, dhr, risk analysis and servicemax, the root cause of the leakage of waste not contained within the instrument was a worn waste bottle.The customer called regarding a worn waste bottle causing a leakage of waste outside of the instrument.They had noticed that the quick connect on the waste bottle cap was broken and did not allow fluid to pass into the tank.The tsr (technical service representative) on the phone sent the customer a new waste bottle (pn 659605).The customer was able to install the part with no issues and the instrument was reported to be functioning as expected with the issue resolved.No parts were requested for evaluation as the replaced part is not returnable and was discarded.Although the leakage of biohazard has the potential for injury and contamination, no customer or bd personnel came in direct contact and was thus not harmed due to the issue.The leakage was not under pressure and did not significantly increase the risk of exposure.The customer confirmed that though patient samples were used, they were not used in any treatment due to the leakage and didn¿t harm the patient in any way.The safety risk is severe, s4, though there was no impact to customer health or safety.Service max review: review of related work order #: (b)(4), case # (b)(4).Install date: n/a.Defective part number: 659605.Work order notes: subject / reported: defective waste bottle.Problem description: defective waste bottle.Work performed: sent the customer a new bottle (659605), she received and installed it and it resolved the issue.Cause: n/a.Solution: sent the customer a new bottle (659605), she received and installed it and it resolved the issue.Case comments: steps taken with customer/troubleshooting: the customer reports that the tan quick connect on the waste bottle cap is broken, not allowing fluid to go into the tank and causing it to pool up on the cap.The instrument is down and out of service.They have samples that will keep over the weekend, but must be run on monday, so as a courtesy i am going to send her a new waste bottle (p/n 659605) so that they will not lose their samples.Next steps (if necessary): sending the customer a new waste bottle.Returned sample evaluation: a return sample was not requested because the replaced part is not returnable and was discarded.Risk analysis: risk management file part # 10000176773, rev/vers.D, facsvia clinical software version 1.2 risk analysis was reviewed.No new hazards have been identified and the current mitigation is sufficient.Hazard(s) identified? yes/no? id: (b)(4).Hazard event: exposure to bio-hazardous material during instrument startup.Cause of event: waste bottle overflows.Harmful effects; exposure to biohazardous material.Risk control: sy-3126 ¿ safety - biohazard; pcyt-648 ¿ labeling biohazard; pcyt-2908 ¿ labeling waste bottle biohazard; cyfr-3264 ¿ stop fluidics if waste tank full at startup; cyfr-699 ¿ startup and shutdown fluidics operations user will apply the universal precaution - instructions for use guide - chapter on startup and shutdown.User instructed to empty waste bottle before starting the cytometer - instructions for use guide - chapter on startup and shutdown.Wear suitable ppe ¿ biological safety ¿ safety and limitations guide, if properly shutdown then bio-hazardous material should not be present.User instructed to properly shutdown the cytometer after use, which runs bleach through the system - instructions for use guide - chapter on startup and shutdown.Implementation verification: tp-266; tp-190; 23-14661-00 bd facsvia¿ safety and limitations; drawing ¿ 659605- assy, 2000ml bottle facsvia waste; see pcyt-2908; 23-14662-00 bd facsvia¿ instructions for use; level sensor in waste bottle; effective verification: design verification report ¿ pm053 cytometer, generation iv; tp-152 fw fluidics startup and shutdown communications, sheath usage, and maintenance pass date: 26-aug-2014.Probability: 1.Severity: 4.Risk index: 4.Residual risk evaluation: a.New hazards: none.Mitigation(s) sufficient, yes/no? root cause: based on the investigation results the root cause of the leakage of waste not contained within the instrument was a worn waste bottle.Conclusion: based on the investigation results the root cause of the leakage of waste not contained within the instrument was a worn waste bottle.The customer had noticed the leakage and cause for it, so they called and requested a replacement waste bottle.When the replacement part arrived the customer was able to install it without any issue and the instrument was reported to be functioning as expected.No one was harmed or injured, and no medical diagnosis was performed due to the leakage.The safety risk is severe, s4, though there was no impact to customer health or safety.H3 other text : see h10.
Event or Problem Description
It was reported while using bd facsvia¿ system waste leaked outside of instrument.There was no user impact.The following information was provided by the initial reporter: defective waste bottle.Steps taken with customer/troubleshooting: the customer reports that the tan quick connect on the waste bottle cap is broken, not allowing fluid to go into the tank and causing it to pool up on the cap.The instrument is down and out of service.They have samples that will keep over the weekend, but must be run on monday, so as a courtesy i am going to send her a new waste bottle (p/n 659605) so that they will not lose their samples.Are you using this product for clinical diagnostic test? yes.Were erroneous results reported and used to treat a patient? no.Was there any injury or potential injury? no.Resolution achieved? yes.Follow up required? yes.Was there a fluidic leak or spill? yes.1.Was the leak/spill contained within the instrument? no.2.Was the leak/spill in a customer accessible location? yes.3.What was the fluid that leaked/spilled? waste 4.What is the source of leak/spill? (waste or non-waste line) waste.5.Was the customer exposed to blood or bodily fluids? no.6.Was there any physical harm to the customer as a result of the leak no.Additionally, the fse provided the following additional information: the leaking waste was not mixed with bleach or a decontaminate at the point of the leak.

• Brand Name: BD FACSVIA SYSTEM
• Common Device Name: FLOW CYTOMETRIC REAGENTS AND ACCESSORIES
• Manufacturer (Section D): BECTON, DICKINSON AND COMPANY, BD BIOSCIENCES; 2350 qume drive; san jose CA 95131
• MDR Report Key: 11342899
• Report Number: 2916837-2021-00055
• Device Sequence Number: 3479122
• Product Code: OYE
• UDI-Device Identifier: 00382906623867
• UDI-Public: 00382906623867
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: BK150307
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: other,user facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/20/2021

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
• Operator of Device: Other
• Device Model Number: 662386
• Device Catalogue Number: 662386
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 01/22/2021
• Supplement Date Received by Manufacturer: 07/20/2021
• Initial Report FDA Received Date: 02/18/2021
• Supplement Report FDA Received Date: 07/29/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1