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	10/19/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H.3.A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.
Event or Problem Description
It was reported that during usage of bd facscanto¿ ii carryover was observed.The following information was provided by the initial reporter: customer reported 'we have the same problem on facscanto ii with carry over/contamination of the instrument 1.Were samples contaminated as a consequence of this issue? yes 2.Are there erroneous results on patient samples from diagnostic test? (if no, no further questions required.If yes or unknown answer question 3) no.
Additional Manufacturer Narrative
H.6 investigation summary: based on the investigation results, the reported issue for the carryover was confirmed.Investigation results that were performed on the indicated failure mode were the following : the potential cause of the carryover was the blue laser fiber being out of specification and a dirty flowcell.The dhr was reviewed to confirm the instrument met all the manufacturing specifications prior to release.The field service representative (fsr) performed a field visit.The fsr performed a series of standard tasks during preventive maintenance (pm).After the works performed during the pm, the instrument was tested and was meeting specifications.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 that during usage of bd facscanto¿ ii carryover was observed.The following information was provided by the initial reporter: customer reported 'we have the same problem on facscanto ii with carry over/contamination of the instrument.1.Were samples contaminated as a consequence of this issue? yes 2.Are there erroneous results on patient samples from diagnostic test? (if no, no further questions required.If yes or unknown answer question 3) no.

• 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: 18610710
• Report Number: 2916837-2024-00007
• Device Sequence Number: 14054942
• Product Code: OYE
• UDI-Device Identifier: 00382903389629
• UDI-Public: (01)00382903389629
• Combination Product (Y/N): N
• Initial Reporter Country: NO
• 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: Other,Foreign,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/22/2024

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: 10/23/2023
• Supplement Date Received by Manufacturer: 03/22/2024
• Initial Report FDA Received Date: 01/30/2024
• Supplement Report FDA Received Date: 03/25/2024
• 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