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 Fluid/Blood Leak (1250)

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

Event Date 06/02/2022

Event Type  malfunction  

Event Description

It was reported that while using bd facscanto ii cytometer 4/2 system ivd liquid leaked from the sheath filter connection.The following information was provided by the initial reporter: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? 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.

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 liquid leaked from the sheath filter connection.The following information was provided by the initial reporter: 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? 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.

Manufacturer Narrative

Mfr report.# 2916837-2022-00161 was filed against the facscanto because the facscan instrument that the event occurred on was not registered in the database the complaint was initially opened in.There was no failure on this facscanto, therefore the mdr was filed incorrectly.Mfr report # 2916837-2022-00186 correctly captures this incident on the facscan.

• 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: 14892824
• MDR Text Key: 297782779
• Report Number: 2916837-2022-00161
• Device Sequence Number: 1
• Product Code: GKZ
• UDI-Device Identifier: 00382903389605
• UDI-Public: 00382903389605
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K062087
• 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: 09/06/2022

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 Model Number: 338960
• Device Catalogue Number: 338960
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/02/2022
• Initial Date FDA Received: 07/01/2022
• Supplement Dates Manufacturer Received: 09/06/2022
• Supplement Dates FDA Received: 09/06/2022
• 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