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

Catalog Number 661765

Device Problem Fluid/Blood Leak (1250)

Patient Problem No Patient Involvement (2645)

Event Date 08/21/2020

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 waste line leaked outside of instrument during use with a bd facsmelody¿.The following information was provided by the initial reporter, translated from (b)(6) to english: nothing arrives in the waste tank.Was the leak contained within the instrument? no.Was the leak in a customer accessible location? yes.Was there spray of fluid under pressure? no.What was the fluid that leaked? facsflow/ethanol.What is the source of leak -- waste line or non-waste line? waste line.Was the customer exposed to blood or bodily fluids? no.

Manufacturer Narrative

After further review is no longer reportable.This is not mdr reportable.There was no report of serious injury, medical intervention, or reportable device malfunction.Leakage of non-pressurized fluids are unlikely to lead to a serious injury or death due to the passive nature is not likely to lead contact of the user or other person.As a result is null and void.

Event Description

It was reported that waste line leaked outside of instrument during use with a bd facsmelody¿.The following information was provided by the initial reporter, translated from german to english: nothing arrives in the waste tank.1.Was the leak contained within the instrument? no.2.Was the leak in a customer accessible location? yes.3.Was there spray of fluid under pressure? no.4.What was the fluid that leaked? facsflow/ethanol.5.What is the source of leak -- waste line or non-waste line? waste line.6.Was the customer exposed to blood or bodily fluids? no.

• Brand Name: BD FACSMELODY
• Type of Device: NA
• Manufacturer (Section D): BECTON, DICKINSON AND COMPANY, BD BIOSCIENCES; 2350 qume drive; san jose CA 95131
• MDR Report Key: 10524343
• MDR Text Key: 242733524
• Report Number: 2916837-2020-00116
• Device Sequence Number: 1
• Product Code: KET
• 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: 04/19/2021

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 Catalogue Number: 661765
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 08/21/2020
• Initial Date FDA Received: 09/11/2020
• Supplement Dates Manufacturer Received: 04/19/2021
• Supplement Dates FDA Received: 04/19/2021
• Patient Sequence Number: 1
• Patient Outcome(s): Other