MAUDE Adverse Event Report: BECTON, DICKINSON AND COMPANY, BD BIOSCIENCES BD FACSCANTO II FLOW CYTOMETER; COUNTER, DIFFERENTIAL CELL

Model Number 338960

Device Problem Device Contamination with Chemical or Other Material (2944)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/13/2020

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.(b)(4).

Event Description

It was reported that while using bd facscanto¿ ii flow cytometer patient sample was contaminated due to foreign matter clogging instrument.The following information was provided by the initial reporter, translated from (b)(6) to english: unit 5: the sample pattern is bad due to a slight clogging.Please confirm the safety check below.Were samples contaminated? yes.Was testing performed on patient samples intended for clinical use? yes.Are there erroneous results on patient samples from diagnostic test? no.

Manufacturer Narrative

After further evaluation of the complaint, it has been determined that the previously submitted mfr report# 2916837-2020-00292 was sent in error.The contaminated sample was not on a patient sample, therefore, this was not is not considered to be a reportable malfunction.

Event Description

It was reported that while using bd facscanto¿ ii flow cytometer patient sample was contaminated due to foreign matter clogging instrument.The following information was provided by the initial reporter, translated from japanese to english: unit 5: the sample pattern is bad due to a slight clogging.Please confirm the safety check below.1.Were samples contaminated? yes.2.Was testing performed on patient samples intended for clinical use? yes.3.Are there erroneous results on patient samples from diagnostic test? no.

• Brand Name: BD FACSCANTO II FLOW CYTOMETER
• 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: 10958755
• MDR Text Key: 219899072
• Report Number: 2916837-2020-00292
• Device Sequence Number: 1
• Product Code: GKZ
• UDI-Device Identifier: 00382903389605
• UDI-Public: 00382903389605
• Combination Product (y/n): N
• PMA/PMN Number: K062087
• 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: 02/02/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/07/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: 338960
• Device Catalogue Number: 338960
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/26/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1