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

Catalog Number	338962
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	11/15/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
E.1 (b)(6).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 that while using bd facscanto¿ ii flow cytometer fsc & ssc signal shift toward the origin.There was no report of user impact.The following information was provided by the initial reporter: the issue is phantom air collecting in the flow cell during sample acquisition causing the scatter plot to shift toward the origin axis.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): no 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.
Event or Problem Description
It was reported that while using bd facscanto¿ ii flow cytometer fsc & ssc signal shift toward the origin.There was no report of user impact.The following information was provided by the initial reporter: the issue is phantom air collecting in the flow cell during sample acquisition causing the scatter plot to shift toward the origin axis.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): no.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.
Additional Manufacturer Narrative
The following fields have been updated with corrected information: g.1 - reporting office - becton dickinson and company bd biosciences san jose ca, 95131.G.1 - reporting office contact - fahmy razak.G.1 - manufacturing site contact - fahmy razak.H.6 investigation summary: based on the investigation results, the reported issue for the fsc and ssc signal shift was confirmed.Investigation results that were performed on the indicated failure mode were the following : the potential cause of the fsc and ssc signal shift was loose air fitting for the tube eject mechanism the customer reported a complaint regarding fsc & ssc signal shift toward the origin.The field service representative (fsr) performed a service visit.They found a loose quick disconnect fitting for the tube eject mechanism and performed a tightening.After the repair, the instrument was tested and was meeting specification.Although the instrument was used for diagnostic testing, the issue was identified and resolved before the patient sample results were used for any diagnosis or treatment.Neither the customer nor any patients were harmed due to this issue.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.

• Brand Name: BD FACSCANTO¿ II
• 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: 18321726
• Report Number: 2916837-2023-00229
• Device Sequence Number: 7026502
• Product Code: OYE
• UDI-Device Identifier: 00382903389629
• UDI-Public: (01)00382903389629
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K141468
• 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): 06/05/2024

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: 338962
• 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: 11/15/2023
• Supplement Date Received by Manufacturer: 06/05/2024
• Initial Report FDA Received Date: 12/13/2023
• Supplement Report FDA Received Date: 06/05/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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