MAUDE Adverse Event Report: BECTON, DICKINSON AND COMPANY, BD BIOSCIENCES BD FACS LYSE WASH ASSISTANT; STATION, PIPETTING DILUTING CLINICAL USE

Model Number 337146

Device Problem Fluid/Blood Leak (1250)

Patient Problems No Patient Involvement (2645); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/15/2021

Event Type  malfunction  

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 Description

It was reported while using bd facs¿ lyse wash assistant biohazard waste leaked outside of instrument.The following information was provided by the initial reporter: the instrument has a leaky waste tank.Was the leak contained within the instrument? no.Is leaked liquid type known? biohazardous or non-biohazardous? biohazardous (waste) liquid.Did the leaked liquid have bleach mixed in? no.Was anyone injured or exposed to the leaked liquid contacting the liquid without proper ppe equipped? no.

Event Description

It was reported while using bd facs¿ lyse wash assistant biohazard waste leaked outside of instrument.The following information was provided by the initial reporter: the instrument has a leaky waste tank.1.Was the leak contained within the instrument? no.2.Is leaked liquid type known? biohazardous or non-biohazardous? biohazardous (waste) liquid.3.Did the leaked liquid have bleach mixed in? no.4.Was anyone injured or exposed to the leaked liquid contacting the liquid without proper ppe equipped? no.

Manufacturer Narrative

H6: investigation summary: scope of issue: the scope of issue is only limited to bd facs lyse wash assistant, part # 337146 and serial # (b)(6).Problem statement: the leakage of biohazard was not contained within the instrument.Manufacturing defect trend: there are zero qns (quality notifications) related to the reported issue.Date range from (b)(6) 2020 to (b)(6) 2021.Complaint trend: there are 4 complaints related to the issue of leakages not contained within the instrument; date range from (b)(6) 2020 to (b)(6) 2021.Manufacturing device history record (dhr) review: dhr part # 337146 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 not contained within the instrument was due to a worn waste tank.The customer called regarding a leaking waste tank (pn 33634907) and requested for one to be sent to them.When the part arrived onsite the customer was able to install the tank onto their instrument without an fse¿s assistance.No parts were requested for evaluation as the waste tank is not a returnable part and was discarded.After the repair the customer confirmed that the instrument was tested and performing as expected.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: (b)(6) 2013.Defective part number: 33634907.Work order notes: subject / reported: 337146 - bd facs lyse wash assistant - waste tank leakage.Problem description: the instrument has a leaky waste tank.Work performed: sent waste tank 33634907.Cause: part worn.Solution: the customer received the new waste tank and successfully installed it on the instrument.Issue is resolved.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 # 337146fmea, rev.03/vers.C, lyse wash assistant fmea disinfectant project was reviewed.No new hazards have been identified and the current mitigation is sufficient.Hazard(s) identified? yes.No.Id: (b)(4).Item: bd disinfectant.Function: contain the waste.Potential failure mode: integrity of waste tank compromised.Potential causes: incompatibility of antifoam with pp waste tank material.Local and next-level effects: waste leaks out of the tank.Hazards: chemical/biohazard due to incompatible material/chemical reaction.Risk controls: disinfectant added to waste tank; samples lysed and/or fixed.Anti-foam msds.Effectiveness verification: refer to memo: steris vesta syde sq product chemical compatibility with anti-foam and waste tank.Probability: 1.Severity: 4.Risk index: 4.Output: none.Mitigation(s) sufficient yes.No.Root cause: based on the investigation results the root cause of the leakage not contained within the instrument was due to a worn waste tank.Conclusion: based on the investigation results, the root cause of the leakage not contained within the instrument was due to a worn waste tank.The customer called regarding the leakage due to a worn waste tank and requested for one to be sent to them.Upon arrival of the part, the customer successfully installed the waste tank onto the instrument.After the repair, the instrument was rebooted, tested, and 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.

• Brand Name: BD FACS LYSE WASH ASSISTANT
• Type of Device: STATION, PIPETTING DILUTING CLINICAL USE
• Manufacturer (Section D): BECTON, DICKINSON AND COMPANY, BD BIOSCIENCES; 2350 qume drive; san jose CA 95131
• MDR Report Key: 11278435
• MDR Text Key: 265817383
• Report Number: 2916837-2021-00044
• Device Sequence Number: 1
• Product Code: JQW
• UDI-Device Identifier: 00382903371464
• UDI-Public: 00382903371464
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,other,user facility
• Type of Report: Initial,Followup
• Report Date: 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
• Device Operator: Other
• Device Model Number: 337146
• Device Catalogue Number: 337146
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 01/15/2021
• Initial Date FDA Received: 02/04/2021
• Supplement Dates Manufacturer Received: 07/20/2021
• Supplement Dates FDA Received: 07/28/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1