MAUDE Adverse Event Report: BECTON, DICKINSON AND COMPANY, BD BIOSCIENCES FACSCALIBUR CYTOMETER 4 COLOR BASIC IVD; COUNTER, DIFFERENTIAL CELL

Model Number 342975

Device Problem Leak/Splash (1354)

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

Event Date 09/24/2021

Event Type  malfunction  

Event Description

It was reported that while using facscalibur cytometer 4 color basic ivd leakage occurred.There was no report of patient impact.The following information was provided by the initial reporter: dripping probe.The specialist replied that: 1.Is the leak fluid or air? liquid/fluid.2.Was the leak contained within the instrument? external/outside leakage of the equipment.3.Was the fluid actively spraying about outside the machine? only when the equipment was on standby.4.Is leaked liquid type known? biohazardous or non-biohazardous? saline solution used in the equipment, not biological.5.Did the leaked liquid have bleach mixed in? there was no bleach mixed.6.Was anyone injured due to the leaked liquid? there were no injured people.

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.

Manufacturer Narrative

After further evaluation of the complaint, it has been determined that the previously submitted mfr report# 2916837-2021-00407 was sent in error.Information regarding leak stated that the leakage was contained, therefore, this is not considered to be a reportable malfunction.

Event Description

It was reported that while using facscalibur cytometer 4 color basic ivd leakage occurred.There was no report of patient impact.The following information was provided by the initial reporter: dripping probe.The specialist replied that: 1.Is the leak fluid or air? liquid/fluid.2.Was the leak contained within the instrument? external/outside leakage of the equipment.3.Was the fluid actively spraying about outside the machine? only when the equipment was on standby.4.Is leaked liquid type known? biohazardous or non-biohazardous? saline solution used in the equipment, not biological.5.Did the leaked liquid have bleach mixed in? there was no bleach mixed.6.Was anyone injured due to the leaked liquid? there were no injured people.

• Brand Name: FACSCALIBUR CYTOMETER 4 COLOR BASIC 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: katie swenson ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 12665897
• MDR Text Key: 284177781
• Report Number: 2916837-2021-00407
• Device Sequence Number: 1
• Product Code: GKZ
• UDI-Device Identifier: 00382903429752
• UDI-Public: 00382903429752
• Combination Product (y/n): N
• Reporter Country Code: BR
• PMA/PMN Number: K923790
• 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: 02/02/2022

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: 342975
• Device Catalogue Number: 342975
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/19/2021
• Initial Date FDA Received: 10/20/2021
• Supplement Dates Manufacturer Received: 02/02/2022
• Supplement Dates FDA Received: 02/02/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/05/2013
• 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