MAUDE Adverse Event Report: BECTON, DICKINSON AND COMPANY, BD BIOSCIENCES BD FACSLYRICS 3L10C INSTRUMENT; FLOW CYTOMETRIC REAGENTS AND ACCESS

Catalog Number	662878
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/04/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
¿a device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.¿.
Event or Problem Description
¿it was reported that while using bdb facslyric the male connector on the cytometer cracked where the waste line connects to the back.The following information was provided by the initial reporter: 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? before waste line.Was the waste mixed with decontaminate/bleach? was the customer/ bd personnel physically in contact with the fluid? no.".
Additional Manufacturer Narrative
Investigation summary: ¿ scope of issue: the scope of issue is only limited to facslyric 3l10c instrument, part # 662878, serial # (b)(6).¿ problem statement: customer reported complaint of a leakage of biohazard not contained within the instrument.¿ manufacturing defect trend: there are 0 qns (quality notifications) related to the reported issue.Date range from 04may2021 to date 04may2022.¿ complaint trend: there are 3 complaints related to the leakage of biohazard not contained within the instrument; pr# 3421978, 4445442, and this one, 5121948.Date range from 04may2021 to date 04may2022.¿ manufacturing device history record (dhr) review: dhr part #662878 serial # z662878000213, file #662878-662878-z662878000213-107217430-21, 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 biohazard leak was due to a worn male waste line connector.The customer had initially discovered the leakage and its cause and requested for an fse (field service engineer) visit since they did not have the correct fitting.Upon arrival, the fse found that the customer had already replaced the worn fitting with one from their stock.The fse then inspected the instrument to confirm that the leakage was gone and the fitting was installed correctly, tested the system, and confirmed that the instrument was functioning as expected.No parts were requested for evaluation as tubing is not returnable and was discarded.Although a leakage of waste material poses a hazard of contamination upon contact, the customer confirmed that they were not harmed in any way.Additionally, the leakage was not under pressure and thus did not increase the risk of exposure.This instrument was not being used for clinical tests at the time of the incident and thus did not have any impact on any patients.Proper daily and monthly cleaning and maintenance can help in maintaining an optimal system, and can be found in the bd facslyric¿ clinical system instructions for use, #23-19938-02 rev.1/vers.A.The safety risk of this hazard has been identified to be within the acceptable level.¿ service max review: review of related work order #: 02436787, case # (b)(4).Install date: 31mar2021.Defective part number: n/a.Work order notes: o subject / reported: male fitting is cracked where the waste line connects to the back of the cytometer.O problem description: male fitting is cracked where the waste line connects to the back of the cytometer.Customer does not have correct fitting and is requesting that a fse come in to look at instrument.O work performed: customer had already replaced the fitting from their stock.Verified proper installation and that there was not leak.Ran cst and abort rate test.O cause: fitting.O solution: all tests passed.¿ returned sample evaluation: a return sample was not requested because the parts that were replaced are not returnable and were discarded.¿ risk analysis: risk management file part # 10000063058ra, rev.07/vers.Aa, bd facslyric system risk analysis was reviewed.No new hazards have been identified and the current mitigations are sufficient.Hazard(s) identified? yes or no? o azure id: (b)(4).O id: libivd-ra-73 2.1.16.O reg status: ivd; ruo.O hazard: exposure to biological sample.O cause: failed waste connection.O harmful effects: damage to customer property (other than the instrument).O risk control: robust design connection to the tank.The waste connection to the chassis is housed inside the system.O req link (azure id): n/a.O implementation verification: libivd-se-15-84ar.O effectiveness verification: libivd-se-15-84ar.O probability: 1.O severity: 2.O risk index: 2.O residual risk evaluation: a.O new hazards: none.Mitigation(s) sufficient: yes or no.¿ root cause: based on the investigation results, the root cause of a biohazard leak not contained within the instrument was due to a worn waste line fitting.¿ conclusion: based on the investigation results, the root cause of a biohazard leak not contained within the instrument was due to a worn waste line fitting.Upon arrival, the fse found that the customer had already replaced the worn fitting with one from their stock.After verifying the part¿s proper installation, confirming there was no leakage, and testing the instrument, the instrument was found 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.¿ supporting document: n/a.
Event or Problem Description
¿it was reported that while using bdb facslyric the male connector on the cytometer cracked where the waste line connects to the back.The following information was provided by the initial reporter: 1.Was the leak liquid or air? liquid.2.Was the leak contained within the instrument? not contained.3.Was there spray of liquid? no.4.What was the fluid that leaked? biohazard.5.Did biohazard leak before or after waste line? before waste line.6.Was the waste mixed with decontaminate/bleach? 7.Was the customer/ bd personnel physically in contact with the fluid? no.".

• Brand Name: BD FACSLYRICS 3L10C INSTRUMENT
• Common Device Name: FLOW CYTOMETRIC REAGENTS AND ACCESS
• 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: 14565694
• Report Number: 2916837-2022-00123
• Device Sequence Number: 12032770
• Product Code: OYE
• UDI-Device Identifier: 00382906628787
• UDI-Public: 382906628787
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• PMA/510(K) Number: K170974
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/13/2022

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
• Operator of Device: Other
• Device Catalogue Number: 662878
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/04/2022
• Supplement Date Received by Manufacturer: 05/04/2022
• Initial Report FDA Received Date: 06/01/2022
• Supplement Report FDA Received Date: 07/29/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/01/2023
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown