MAUDE Adverse Event Report: BECTON, DICKINSON AND COMPANY, BD BIOSCIENCES BD FACSCANTO II CYTOMETER 4/2 SYSTEM IVD; COUNTER, DIFFERENTIAL CELL

Model Number 338960

Device Problem Contamination (1120)

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

Event Date 07/21/2022

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 that while using bd facscanto ii cytometer 4/2 system ivd there was carryover.The following information was provided by the initial reporter: "are you using this for clinical diagnostic test? no.Were erroneous results reported and used to treat a patient? no.Was there any injury or potential injury? no.Hts ser (b)(4).Email stats: reported issue: it has carry over issues.For the troubleshooting, we¿ve already changed out both syringes and the sample line tubing and there is still carry-over issues.Customer requests a swap.".

Manufacturer Narrative

Change in material description.This complaint is related to an ruo device and event is no longer reportable.

Event Description

It was reported that while using bd facscanto ii cytometer 4/2 system ivd there was carryover.The following information was provided by the initial reporter: "are you using this for clinical diagnostic test? no.Were erroneous results reported and used to treat a patient? no.Was there any injury or potential injury? no.Hts ser #(b)(6), - email stats: reported issue: it has carry over issues.For the troubleshooting, we¿ve already changed out both syringes and the sample line tubing and there is still carry-over issues.Customer requests a swap.".

• Brand Name: BD FACSCANTO II CYTOMETER 4/2 SYSTEM IVD
• Type of Device: COUNTER, DIFFERENTIAL CELL
• 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: 15153454
• MDR Text Key: 304807635
• Report Number: 2916837-2022-00202
• Device Sequence Number: 1
• Product Code: GKZ
• UDI-Device Identifier: 00382903389605
• UDI-Public: 00382903389605
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K062087
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 08/04/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/02/2022
• 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
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/04/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/22/2012
• 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