MAUDE Adverse Event Report: BECTON, DICKINSON AND COMPANY, BD BIOSCIENCES BD FACSCALIBUR; COUNTER, DIFFERENTIAL CELL

Catalog Number 343023

Device Problem Contamination (1120)

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

Event Date 03/05/2021

Event Type  malfunction  

Manufacturer Narrative

A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.

Event Description

It was reported while using bd facscalibur" contamination is observed.After flushing instrument, the customer reports that the flow chamber is contaminated again.The following information was provided by the initial reporter, translated from (b)(6) to english: the client informs that "i have carried out the maintenance of the calibur as we are but i continue to observe contamination, we need to notify the technical service for its review and more exhaustive washing of cameras" the flushing procedures advised in case (b)(4) appeared to have resolved the problem, but the customer reports that the flow chamber is dirty again.

Manufacturer Narrative

After further evaluation of the complaint, it has been determined that the previously submitted mfr report# 2916837-2021-00131 was sent in error.There was no patient samples involved, therefore, this is not considered to be a reportable malfunction.

Event Description

It was reported while using bd facscalibur¿ contamination is observed.After flushing instrument, the customer reports that the flow chamber is contaminated again.The following information was provided by the initial reporter, translated from spanish to english: the client informs that "i have carried out the maintenance of the calibur as we are but i continue to observe contamination, we need to notify the technical service for its review and more exhaustive washing of cameras".The flushing procedures advised in case (b)(4) appeared to have resolved the problem, but the customer reports that the flow chamber is dirty again.

• Brand Name: BD FACSCALIBUR
• Type of Device: COUNTER, DIFFERENTIAL CELL
• Manufacturer (Section D): BECTON, DICKINSON AND COMPANY, BD BIOSCIENCES; 2350 qume drive; san jose CA 95131
• MDR Report Key: 11602719
• MDR Text Key: 252944313
• Report Number: 2916837-2021-00131
• Device Sequence Number: 1
• Product Code: GKZ
• Combination Product (y/n): N
• PMA/PMN Number: K973483
• 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: 04/16/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/01/2021
• 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
• Date Manufacturer Received: 04/06/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1