MAUDE Adverse Event Report: BECTON, DICKINSON AND COMPANY, BD BIOSCIENCES BD FACSARIA FLOW CYTOMETER

Catalog Number 334079

Device Problem Fluid/Blood Leak (1250)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/20/2020

Event Type  malfunction  

Manufacturer Narrative

Medical device expiration date: na.A device evaluation is anticipated but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.Fda device problem code(s): 1250, fda patient problem code(s): 2199.

Event Description

It was reported that while using a bd facsaria¿ flow waste leakage without bleach was not contained within the instrument.The following information was provided by the initial reporter.It was reported that liquid is dripping from behind the waste drawer.1.Was the leak liquid or air? liquid 2.Was the leak contained within the instrument? not contained 3.Was there spray of fluid under pressure? no spray of liquid 4.What was the fluid that leaked? unknown 5.Did biohazard leak before or after waste line? before waste line 6.Was the waste mixed with decontaminate/bleach? no 7.Was the customer/ bd personnel physically in contact with the fluid? no 8.Where did the physical contact of fluid occur? gloved hand 9.What personal protective equipment (ppe) was being used during the occurrence? gloves 10.Was there any impact to patient samples due to leak? no 11.Was customer/ bd personnel harmed/ injured? no.

Event Description

It was reported that while using a bd facsaria¿ flow waste leakage without bleach was not contained within the instrument.The following information was provided by the initial reporter.It was reported that liquid is dripping from behind the waste drawer.1.Was the leak liquid or air? liquid 2.Was the leak contained within the instrument? not contained 3.Was there spray of fluid under pressure? no spray of liquid 4.What was the fluid that leaked? unknown 5.Did biohazard leak before or after waste line? before waste line 6.Was the waste mixed with decontaminate/bleach? no 7.Was the customer/ bd personnel physically in contact with the fluid? no 8.Where did the physical contact of fluid occur? gloved hand 9.What personal protective equipment (ppe) was being used during the occurrence? gloves 10.Was there any impact to patient samples due to leak? no 11.Was customer/ bd personnel harmed/ injured? no.

Manufacturer Narrative

After further review mfr#(b)(4) 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 FACSARIA FLOW CYTOMETER
• Type of Device: NA
• Manufacturer (Section D): BECTON, DICKINSON AND COMPANY, BD BIOSCIENCES; 2350 qume drive; san jose CA 95131
• MDR Report Key: 11003732
• MDR Text Key: 222038747
• Report Number: 2916837-2020-00303
• 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: other,user facility
• Type of Report: Initial,Followup
• Report Date: 06/15/2021

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: 334079
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 11/20/2020
• Initial Date FDA Received: 12/14/2020
• Supplement Dates Manufacturer Received: 06/15/2021
• Supplement Dates FDA Received: 06/16/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1