MAUDE Adverse Event Report: BECTON, DICKINSON AND COMPANY, BD BIOSCIENCES BD FACSMELODY BRVYG 8 COLOR PLATE EU

Catalog Number 662754

Device Problem Fluid/Blood Leak (1250)

Patient Problem No Patient Involvement (2645)

Event Date 10/21/2020

Event Type  malfunction  

Manufacturer Narrative

Medical device expiration date: na.(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 while using a bd facsmelody" brvyg 8 color plate eu there was leakage of fluid from the bottom unit of the instrument.There was no report of patient impact.The following additional information was provided by the customer: was the leak contained within the instrument? no.Was the leak in a customer accessible location? yes.Was there spray of fluid under pressure? yes, the fluid was pressurised @ 70psi.4.What was the fluid that leaked? sheath fluid.What is the source of leak -- waste line or non-waste line? non-waste.Was the customer exposed to blood or bodily fluids? no.Was there any physical harm to the customer as a result of the leak? no.

Event Description

It was reported that while using a bd facsmelody¿ brvyg 8 color plate eu there was leakage of fluid from the bottom unit of the instrument.There was no report of patient impact.The following additional information was provided by the customer: 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? yes, the fluid was pressurised @ 70psi 4.What was the fluid that leaked? sheath fluid 5.What is the source of leak -- waste line or non-waste line? non-waste 6.Was the customer exposed to blood or bodily fluids? no 7.Was there any physical harm to the customer as a result of the leak? no.

Manufacturer Narrative

After further review mfr#2916837-2020-00238 is no longer reportable.This device is for research use only and is not being used for diagnostic testing or patient treatment and is therefore not subject to mdr reporting.

• Brand Name: BD FACSMELODY BRVYG 8 COLOR PLATE EU
• Type of Device: NA
• Manufacturer (Section D): BECTON, DICKINSON AND COMPANY, BD BIOSCIENCES; 2350 qume drive; san jose CA 95131
• MDR Report Key: 10810138
• MDR Text Key: 247266407
• Report Number: 2916837-2020-00238
• 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: 06/21/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/09/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 662754
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 06/21/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1