MAUDE Adverse Event Report: BECTON, DICKINSON AND COMPANY, BD BIOSCIENCES BD FACSCANTO¿ IVD

Catalog Number 337175

Device Problem Fluid/Blood Leak (1250)

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

Event Date 12/14/2022

Event Type  malfunction  

Event Description

It was reported that while using the bd facscanto¿ ivd that there was a leak.The following information was provided by the initial reporter:(b)(6) 20:26:45 (gmt).Customer problem: caller has noticed a puddle on the left side under the canto steps taken with customer/troubleshooting: caller was not able to determine the source of the leak.The caller has tried to check that all quick connects are secure and have replaced the o-rings in the vicinity, but this has not helped.The puddle still comes back.Operators cannot find the source of the leak.

Manufacturer Narrative

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 summary scope of issue: the scope of issue is only limited to bd facscanto ivd, part # 337175 and serial # (b)(6).Problem statement: customer reported complaint regarding leak from left side of the instrument on 14dec2022.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 14dec2021 to 14dec2022.Device history record (dhr) review: dhr part # 337175 serial # (b)(6), file # (b)(4), was reviewed.The instrument met all the manufacturing specifications prior to release.Complaint history review: there are 26 complaints related to as reported code 1 : fluidic ¿ leak ¿ date range from 14dec2021 to 14dec2022.Returned sample analysis: a return sample was not requested because parts replaced are not returnable.Service history review: review of related work order #: (b)(4), case # (b)(4) install date: 31jan2005 defective part number: 59-10092-05 - cpln bdy panl mt 1/8 jd org, 59-10090-05 - coupl ins hose barb pp orn work order notes: subject / reported: (b)(4) -leak from unknown source on left side of canto problem description: operators cannot find the source of the leak work performed: 12/15-while onsite, customer ran start up and there was a slow drip from the cytometer waste quick disconnect.Cytometer booked all day, will be back tomorrow to service cytometer 12/16-replaced all orange waste line male and female quick disconnects.Startups and shutdown ran without any leaks.Cause: broken connectors on the flowcell cause: quick disconnect fittings on waste line were worned and allowed slow drips from cytometer solution: 12/15-while onsite, customer ran start up and there was a slow drip from the cytometer waste quick disconnect.Cytometer booked all day, will be back tomorrow to service cytometer 12/16-replaced all orange waste line male and female quick disconnects.Startups and shutdown ran without any leaks.Parts replaced: 59-10092-05 - cpln bdy panl mt 1/8 jd org, 59-10090-05 - coupl ins hose barb pp orn labeling / packaging review: n/a risk analysis: risk management file part # 338942ra, rev.09/vers.H, ra bd facscanto product family was reviewed.No new hazards have been identified and the current mitigations are sufficient.Hazard(s) identified? yes no.Id : 3.1.12 potential leakage hazard : potential lack of workmanship during assembly.Harmful effects : potential biohazard exposure residual probability: 1 residual severity: 4 residual risk index: 4 potential causes: based on the investigation results, the potential cause was worn quick disconnect fittings on the waste line.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 of the leak was worn quick disconnect fittings on the waste line.The customer reported a complaint regarding a leak from an unknown source on the left side of the instrument.While on site, the customer ran start up and a slow drip was noted from the cytometer quick disconnect.The field service engineer (fse) confirmed that the quick disconnect fittings on the waste line were worn and allowed slow drips from cytometer.In order to resolve the issue, the fse replaced all the orange waste line male and female quick disconnects.The fse performed startups and shutdowns in order to confirm that there were no further leaks.After the works performed, the instrument is performing as intended.Although the leak could have potentially caused exposure to biohazardous material, the customer confirmed that there was no physical contact with the leaked fluid.No one was injured or harmed due to this issue.The safety risk of this hazard has been identified to be within the acceptable level.Conclusion: based on the investigation results, complaint was confirmed and the potential cause was worn of the quick disconnect fittings on the waste line.The field service engineer (fse) confirmed that the quick disconnect fittings on the waste line were worn and allowed slow drips from cytometer and proceeded to replace all the orange waste line male and female quick disconnects.After the works performed, the instrument is 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 h3 other text : see h.10.

Event Description

It was reported that while using the bd facscanto¿ ivd that there was a leak.The following information was provided by the initial reporter: (b)(6) : (b)(6) 2022 20:26:45 (gmt) customer problem: caller has noticed a puddle on the left side under the canto steps taken with customer/troubleshooting: caller was not able to determine the source of the leak.The caller has tried to check that all quick connects are secure and have replaced the o-rings in the vicinity, but this has not helped.The puddle still comes back operators cannot find the source of the leak.

• Brand Name: BD FACSCANTO¿ IVD
• Type of Device: NA
• 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: 16052188
• MDR Text Key: 306451736
• Report Number: 2916837-2022-00372
• Device Sequence Number: 1
• Product Code: OYE
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 02/28/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/27/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 337175
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/28/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/22/2012
• 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