MAUDE Adverse Event Report: BECTON, DICKINSON AND COMPANY, BD BIOSCIENCES BD FACSMELODY BRV 9 COLOR

Catalog Number 661634

Device Problem Fluid/Blood Leak (1250)

Patient Problems No Known Impact Or Consequence To Patient (2692); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 05/29/2020

Event Type  malfunction  

Manufacturer Narrative

Medical device expiration date: na.Initial reporter phone #: (b)(6).A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.(b)(4).

Event Description

It was reported that leakage from waste line outside of instrument occurred during use with a bd facsmelody¿ brv 9 color.The following information was provided by the initial reporter, translated from (b)(6) to english: facsmelody-sheath fluid connection cable is faulty, the waste liquid is leaked when the nozzle is closed, there is no direct contact, and no physical safety hazard is caused to the personnel on site research.Seen the leakage from inside the instrument to the outside of the instrument.The leakage wasn't in a customer accessible location.The leaked liquid was waste fluid.Leakage came from waste line.No blood or bodily fluids exposed to the customer.No harm to the customer due to the leak.No physical harm to the fse and customer due to the issue.It was not a safety related issue and there didn't smell came out.

Event Description

It was reported, that leakage from waste line outside of instrument occurred, during use with a bd facsmelody¿ brv 9 color.The following information was provided by the initial reporter, translated from chinese to english: facsmelody-sheath fluid connection cable is faulty.The waste liquid is leaked, when the nozzle is closed.There is no direct contact, and no physical safety hazard is caused to the personnel on site.Research: 1.Seen the leakage from inside the instrument to the outside of the instrument.2.The leakage wasn't in a customer accessible location.3.The leaked liquid was waste fluid.4.Leakage came from waste line.5.No blood or bodily fluids exposed to the customer.6.No harm to the customer, due to the leak.7.No physical harm to the fse and customer, due to the issue.8.It was not a safety related issue.And there didn't smell came out.

Manufacturer Narrative

Investigation summary: the investigation was performed.And based on the review of the complaint trend, defect trend, dhr, risk analysis and service max, the root cause of waste leakage without bleach, not contained within the instrument was, due to a clog in the closed loop nozzle.A clog in the closed loop nozzle, or in the fluidics line, may lead to a low pressure build up.Potentially causing a leak at connections or seals.The fse (field service engineer) confirmed, the issue and cleared any debris and blockage.No return sample was requested for evaluation, because no parts were replaced.After the repair, the instrument was tested.And was performing normally with no further leaks.

• Brand Name: BD FACSMELODY BRV 9 COLOR
• Type of Device: NA
• Manufacturer (Section D): BECTON, DICKINSON AND COMPANY, BD BIOSCIENCES; 2350 qume drive; san jose CA 95131
• MDR Report Key: 10460272
• MDR Text Key: 241678828
• Report Number: 2916837-2020-00099
• Device Sequence Number: 1
• Product Code: GKZ
• Combination Product (y/n): N
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,other,user facility
• Type of Report: Initial,Followup
• Report Date: 03/18/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/27/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 661634
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/16/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other