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 Leak/Splash (1354)

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

Event Date 02/03/2022

Event Type  malfunction  

Event Description

It was reported that while using bd facs¿ lyse wash assistant biohazardous waste leaked outside of the instrument.There was no user impact.The following information was provided by the initial reporter, translated from (b)(6) to english: the waste tank itself is leaky and waste is leaking out.Was there a fluid leak? yes.Was it contained within the instrument ? not contained.Was there spray of fluid under pressure? no.Was it biohazardous or non biohazardous ? biohazardous.Was anyone harmed for injured by any fluids leaked ? no.

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.

Manufacturer Narrative

H.6.Investigation: scope of issue: the scope of issue is only limited to bd facs lyse wash assistant, part # 337146, and serial # (b)(6).Problem statement: customer reported complaint on leakage of biohazard not contained within the instrument.Manufacturing defect trend: there are zero qns (quality notifications) related to the reported issue.Date range from 03feb2020 to 03feb2021.Complaint trend: there are (b)(4) complaints related to the issue of a waste leakage not contained within the instrument.Date range from 03feb2020 to 03feb2021.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 waste 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 of this hazard has been identified to be within the acceptable level.Service max review: review of related work order #: n/a, case # (b)(4).Install date: (b)(6) 2016 defective part number: 33634907 - assembly waste bottle services.Case comments: (2/8/2022 3:57 am): new value: replaced defective tank 33634907 - device works.(2/8/2022 3:55 am): customer called: the tank has arrived, the case can be closed.Devices run without problems (2/8/2022 3:53 am): on the pod herewith attached, you can see that all 3 waste bottles were delivered.(2/8/2022 2:34 am): trasport desk asked for update as no tracking is available.(2/3/2022 3:54 am): the waste tank itself is leaky and waste is leaking out.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 of waste 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 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 of this hazard has been identified to be within the acceptable level.

Event Description

It was reported that while using bd facs¿ lyse wash assistant biohazardous waste leaked outside of the instrument.There was no user impact.The following information was provided by the initial reporter, translated from german to english: the waste tank itself is leaky and waste is leaking out.1.Was there a fluid leak? yes.2.Was it contained within the instrument ? not contained.3.Was there spray of fluid under pressure? no.4.Was it biohazardous or non biohazardous ? biohazardous.5.Was anyone harmed for injured by any fluids leaked ? no.

• 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
• 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: 13538284
• MDR Text Key: 287280048
• Report Number: 2916837-2022-00029
• Device Sequence Number: 1
• Product Code: JQW
• UDI-Device Identifier: 00382903371464
• UDI-Public: 00382903371464
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 03/21/2022

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 Model Number: 337146
• Device Catalogue Number: 337146
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/03/2022
• Initial Date FDA Received: 02/15/2022
• Supplement Dates Manufacturer Received: 03/21/2022
• Supplement Dates FDA Received: 03/31/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/26/2016
• 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