MAUDE Adverse Event Report: BECTON, DICKINSON AND COMPANY, BD BIOSCIENCES BD FACS CALIBUR¿

Catalog Number 343023

Device Problem Fluid/Blood Leak (1250)

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

Event Date 06/20/2022

Event Type  malfunction  

Event Description

It has been reported that the bd facs calibur¿ has been found leaking uncontained waste fluid.The following has been provided by the initial reporter: please confirm the safety check below.Was the leak fluid or air? fluid.Was the leak contained within the instrument? no.Was there spray of fluid under pressure? no.What was the fluid that leaked? non biohazard.Did biohazard leak before or after waste line? after waste line.Was the waste mixed with decontamination or bleach? no.Was the customer/bd personnel physically in contact with the fluid? no.Liquid is leaking from below between the sheath tank and the waste liquid tank.When the flow is set to m or h, liquid leaks from around the flow cell.

Manufacturer Narrative

A device evaluation and/or device history review is anticipated, but is not complete.Upon completion, a supplemental report will be filed.

Manufacturer Narrative

After further evaluation of the complaint, it has been determined that the previously submitted report was sent in error.It was determined the leakage was non-biohazard, therefore this is not considered to be a reportable malfunction.

Event Description

It has been reported that the bd facs calibur¿ has been found leaking uncontained waste fluid.The following has been provided by the initial reporter: please confirm the safety check below.1.Was the leak fluid or air¿ fluid.2.Was the leak contained within the instrument no.3.Was there spray of fluid under pressure? no.4.What was the fluid that leaked? non biohazard.5.Did biohazard leak before or after waste line? after waste line.6.Was the waste mixed with decontamination or bleach? no.7.Was the customer/bd personnel physically in contact with the fluid? no.Liquid is leaking from below between the sheath tank and the waste liquid tank.When the flow is set to m or h, liquid leaks from around the flow cell.

• Brand Name: BD FACS CALIBUR¿
• 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: 14890171
• MDR Text Key: 300441856
• Report Number: 2916837-2022-00169
• Device Sequence Number: 1
• Product Code: GKZ
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 10/04/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/01/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 343023
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/04/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/21/2017
• 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