MAUDE Adverse Event Report: BECTON, DICKINSON AND COMPANY, BD BIOSCIENCES BD FACS¿ LYSE WASH ASSISTANT; SEE H.10

Model Number 337146

Device Problem Leak/Splash (1354)

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

Event Date 01/11/2023

Event Type  malfunction  

Manufacturer Narrative

Common device name: station, pipetting diluting clinical use.Device evaluated by mfr: a device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.Initial reporter e-mail: (b)(6).Initial reporter phone number: (b)(6).

Event Description

It was reported that while using the bd facs¿ lyse wash assistant that there was a waste leak.The following information was provided by the initial reporter: waste tank leaking.

Event Description

It was reported that while using the bd facs¿ lyse wash assistant that there was a waste leak.The following information was provided by the initial reporter: waste tank leaking.

Manufacturer Narrative

H.6 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 complaint regarding waste tank leak on (b)(6) 2023.This poses the risk of harming or injuring the customer or patient due to contact with the fluid.The instrument was repaired and found to be functioning as expected, and neither the customer nor any patients were harmed due to this issue.¿ manufacturing defect trend: there are zero qns (quality notifications) related to the reported issue.Date range from 11jan2022 to 11jan2023.¿ 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.¿ complaint history review: there are 64 complaints related to as reported code 1: fluidic ¿ leak.Then further filtered by as analyzed code 1, there are 10 complaints remaining:date range from 11jan2022 to 11jan2023.¿ returned sample analysis: a return sample was not requested because part replaced is not returnable and was discarded.¿ service history review: review of related work order #: (b)(4), case # (b)(4) install date: 24jul2012 defective part number: na work order notes: o subject / reported: waste tank leaking o problem description: waste tank leaking o work performed: (b)(6) 2022: spare parts arrived at the customer.Spare part was "installed" by the customer himself.Function of the device again in order.Workorder will be closed after telephone consultation with the customer.O cause: waste canister defective o solution: exchange of the waste canister o parts replaced: na ¿ labeling / packaging review: n/a ¿ risk analysis: risk management file part # 337146fmea, rev.04/vers.D, lyse wash assistant fmea 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 end effects: biohazard and chemical hazard o residual probability: 1 o residual severity: 4 o residual risk index: 4 ¿ potential causes: based on the investigation results, the potential cause was determined to be a defective waste canister.¿ investigation result / analysis: the investigation was performed and based on the review of complaint trend, defect trend, dhr review, risk analysis, and service activity review, the potential cause was determined to be a defective waste canister.The customer reported a complaint regarding leak from the waste tank.Spare parts were provided to the customer.The customer consulted with the field service engineer (fse) remotely and installed the spare waste canister.After the replacement, the instrument was performing as intended.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.Proper daily and monthly cleaning procedures can be found under ¿maintenance¿ in the user guide; bd facs¿ lyse wash assistant user¿s guide, #23-11113-00 rev.1/vers.A, page 101.¿ conclusion: based on the investigation results, complaint was confirmed, and the potential cause was determined to be a defective waste canister.The customer reported a complaint regarding leak from the waste tank.The customer consulted with the field service engineer (fse) remotely and installed a spare waste canister.After the replacement, the instrument was performing as intended.Based on the investigation results a capa is not required because the issue was resolved and there was no impact to customer and patient health or safety.¿ supporting document: n/a.

• Brand Name: BD FACS¿ LYSE WASH ASSISTANT
• Type of Device: SEE H.10
• 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: 16218056
• MDR Text Key: 308936230
• Report Number: 2916837-2023-00007
• 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: Foreign,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 03/03/2023

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: 01/11/2023
• Initial Date FDA Received: 01/20/2023
• Supplement Dates Manufacturer Received: 03/03/2023
• Supplement Dates FDA Received: 03/08/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/30/2014
• 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