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 06/14/2022

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 while using bd facs¿ lyse wash assistant leakage of biohazard coming from the instrument was detected.The customer reports there is a leakage from the right hand side of the instrument.It appears the leaked fluid is waste solution as it is slightly red in color."was the leak liquid or air?" liquid."was the leak contained within the instrument?" not contained."was there spray of liquid?" no."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

H.6 investigation summary: ¿ manufacturing defect trend: there are zero qns (quality notifications) related to the reported issue.Date range from 14jun2021 to 14jun2022.¿ complaint trend: there are 8 complaints related to the issue of the instrument's waste tank leaking outside of the instrument; pr#3358710, 3478361, 3616695, 4111868, 4400830, 4400840, 4400846, and this one, 5376473.Date range from 14jun2021 to 14jun2022.¿ 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 could not be determined.An fse (field service engineer) was sent onsite to observe the issue and started by inspecting the instrument which was found to be clean.They then ran a full sample rack with 40 tubes to check for leakages but there were no leakages found.The instrument was functioning as expected and no parts were requested for evaluation as there were no parts replaced.The leakage was not under pressure and did not significantly increase the risk of exposure.The safety risk of this hazard has been identified to be within the acceptable level.¿ service max review: review of related work order #: (b)(4), case # (b)(4).Install date: 11sep2017.Defective part number: n/a.Work order notes: o subject / reported: 337146 - bd facs lyse wash assistant - leakage from right side of the instrument.O work performed: inspection of the instrument.There is no signs or traces from any leakage inside the instrument.The bottom and all parts are very clean.Ran a fully loaded sample rack ( 40 tubes ) and checked with a light for signs of a leakage.All tubings are well connected, there 's no leaks nor any sample well flooding.Could not find any issue.It is possible that the waste container of from the customer has a little crack on the front.That would explain the leakage underneath the instrument, as the waste container is slightly sticking out of the instrument at the front side.O cause: no issue found.O solution: no issue found, might be an external problem.¿ returned sample evaluation: a return sample was not requested because there were no replaced parts during this visit.¿ risk analysis: risk management file part # 337146fmea, rev.04/vers.D, 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 o id: 20.1.O item: bd disinfectant.O function: contain the waste.O potential failure mode: integrity of waste tank compromised.O potential causes: incompatibility of antifoam with pp waste tank material.O local and next-level effects: waste leaks out of the tank.O hazards: chemical/biohazard due to incompatible material/chemical reaction.O risk controls: disinfectant added to waste tank; samples lysed and/or fixed; anti-foam msds.O effectiveness verification: refer to memo: steris vesta syde sq product chemical compatibility with anti-foam and waste tank.O probability: 1 o severity: 4 o risk index: 4 o 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 could not be confirmed.¿ conclusion: based on the investigation results the root cause of the leakage not contained within the instrument could not be confirmed.The fse performed an inspection on the instrument upon their arrival.They didn¿t find any traces of leakages within the instruments and the instrument seemed clean.The fse then ran a fully loaded sample tube rack to observe for leakages, but there were no leaks or overflows.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 of this hazard has been identified to be within the acceptable level.¿ supporting document:.

Event Description

It was reported that while using bd facs¿ lyse wash assistant leakage of biohazard coming from the instrument was detected.The following information was provided by the initial reporter: "the customer reports there is a leakage from the right hand side of the instrument.It appears the leaked fluid is waste solution as it is slightly red in colour.¿ was the leak liquid or air? liquid.¿ was the leak contained within the instrument? not contained.¿ was there spray of liquid? no.¿ 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: 14837093
• MDR Text Key: 300828055
• Report Number: 2916837-2022-00163
• Device Sequence Number: 1
• Product Code: JQW
• UDI-Device Identifier: 00382903371464
• UDI-Public: 00382903371464
• Combination Product (y/n): N
• Reporter Country Code: BE
• 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: 09/22/2022

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: 06/14/2022
• Initial Date FDA Received: 06/27/2022
• Supplement Dates Manufacturer Received: 09/01/2022
• Supplement Dates FDA Received: 09/24/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/29/2017
• 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