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

Catalog Number	338960
Medical Device Problem Code	Incorrect, Inadequate or Imprecise Result or Readings (1535)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/30/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H.3.A device evaluation and/or device history review is anticipated but is not complete.Upon completion, a supplemental report will be filed.
Event or Problem Description
It was reported by the customer that bd facscanto¿ ii flow cytometer sip is clogged with zero events.The following information was provided by the initial reporter: leak checklist summary: 1.Did any liquid leakage or splash or spray come into contact with eyes or mouth or any mucous membrane or non-intact(broken) skin? if no, stop- no further questions required: -no.Patient samples checklist summary: 1.Are there erroneous results on patient samples from diagnostic test? (if yes or unknown, go to question #2.If no, no further questions required.): -yes.2.Was there any delay of treatment due to the issue? (go to question #3): unknown -yes.3.If patient samples were redrawn, was there any change or delay of treatment? (go to question #4): -no.4.Was there any physical harm/injury to the patient due to the issue? (if yes or unknown, go to question #5.If no, no further questions required): -no.5.Provide details - how and to what extent? (go to question #6): -patient samples were not released.6.What is the current medical status? no further questions required: -patient samples were not released.
Additional Manufacturer Narrative
Investigation summary: based on the complaint trend, defect trend, dhr, risk analysis, and servicemax, the complaint was confirmed, and the potential cause of erroneous results was determined to be debris in the flow cell.To resolve the issue fse ran stylet through sip and ran startup along with flow cell fill/drain.Fse ran subsequent tests with cab beads and 7 color setup tests.The instrument is functioning as expected.Complaints received for this device and reported condition will continue to be tracked and trended.Information will be captured on trend reports and monitored.Our business team regularly reviews the collected data for identification of emerging trends.
Event or Problem Description
It was reported by the customer that bd facscanto¿ ii flow cytometer sip is clogged with zero events.The following information was provided by the initial reporter: leak checklist summary: 1.Did any liquid leakage or splash or spray come into contact with eyes or mouth or any mucous membrane or non-intact(broken) skin? if no, stop- no further questions required: no.Patient samples checklist summary: 1.Are there erroneous results on patient samples from diagnostic test? (if yes or unknown, go to question #2.If no, no further questions required.): yes.2.Was there any delay of treatment due to the issue? (go to question #3): unknown yes.3.If patient samples were redrawn, was there any change or delay of treatment? (go to question #4): no.4.Was there any physical harm/injury to the patient due to the issue? (if yes or unknown, go to question #5 if no, no further questions required): no.5.Provide details - how and to what extent? (go to question #6): patient samples were not released.6.What is the current medical status? no further questions required.: patient samples were not released.

• Brand Name: BD FACSCANTO¿ II FLOW CYTOMETER
• Common Device Name: 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: fahmy razak - mdr ; 2350 qume drive; san jose, CA 95131 ; 4089542435
• MDR Report Key: 18812866
• Report Number: 2916837-2024-00017
• Device Sequence Number: 11847927
• Product Code: GKZ
• UDI-Device Identifier: 00382903389605
• UDI-Public: 00382903389605
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K062087
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/26/2024

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
• Operator of Device: Other
• Device Catalogue Number: 338960
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/30/2024
• Supplement Date Received by Manufacturer: 03/26/2024
• Initial Report FDA Received Date: 02/29/2024
• Supplement Report FDA Received Date: 03/29/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/22/2012
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown