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 Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/13/2021

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 bd facs¿ lyse wash assistant was leaking biohazard that was not contained within the instrument.The following information was provided by the initial reporter: customer reports a leaky waste tank.Was the leak liquid or air? liquid.Was the leak contained within the instrument? not contained.Was there spray of liquid? drips of waste.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

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: customer reported a complaint on a waste leakage without bleach not contained within the instrument.Manufacturing defect trend: there are zero qns (quality notifications) related to the reported issue.Date range from 13dec2020 to 13dec2021.Complaint trend: there are 9 complaints related to the issue of a waste leakage not contained within the instrument; date range from 13dec2020 to 13dec2021.Manufacturing device history record (dhr) review: dhr part # 337146 serial # (b)(6), file # (b)(6), 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 the tsr (technical service representative) assisting them sent out a replacement.When the part arrived onsite the customer was able to install the tank onto their instrument with no reported issues.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) 2017.Defective part number: 33634907 ¿ assembly waste bottle services work order notes: subject / reported: 337146 - bd facs lyse wash assistant - waste tank is leaking problem description: customer reports a leaky waste tank work performed: defective 33634907 replaced cause: defects 33634907 solution: defects 33634907 replaced; device is running! internal notes: (2021-12-21 07:51:39z): mrs.(b)(6) is not there, but she asks mr.(b)(6): yes, 33634907 has arrived, device is working, case can be closed (2021- 12-21 07:50:50z): (b)(6) +43724241593897 called: mrs.(b)(6): please call (b)(6), she should be there.(b)(6) called: ms.(b)(6): (2021-12-13 14:05:28z): (b)(6) called (b)(6): case checklist completed, ts sends the tank 33634907 - assembly waste bottle services - customer reports when the tank has arrived.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.(b)(6) 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)(6) 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 the tsr assisting them sent a replacement tank 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 is severe, s4, though there was no impact to customer health or safety.H3 other text : see h10.

Event Description

It was reported that bd facs¿ lyse wash assistant was leaking biohazard that was not contained within the instrument.The following information was provided by the initial reporter: "customer reports a leaky waste tank was the leak liquid or air? liquid, was the leak contained within the instrument? not contained, was there spray of liquid? drips of waste, 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.".

• 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: 13101886
• MDR Text Key: 290162445
• Report Number: 2916837-2021-00506
• Device Sequence Number: 1
• Product Code: JQW
• UDI-Device Identifier: 00382903371464
• UDI-Public: 00382903371464
• Combination Product (y/n): N
• Reporter Country Code: AU
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Consumer
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 02/28/2022

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: 12/13/2021
• Initial Date FDA Received: 12/28/2021
• Supplement Dates Manufacturer Received: 02/28/2022
• Supplement Dates FDA Received: 03/04/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/28/2012
• 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