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	10/07/2023
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 that bd facscanto¿ ii system w/fluidics cart tube could not pressurize.The following information was provided by the initial reporter: customer reported error tube could not pressurize.Check wet cart pressure is ok at 65, error occur while using loader.Lifter rod is clean, customer check drawer is properly locked into position.There were no broken wires in the cable beam from the loader.Customer also tried replace bal seal, no damage found on the sit area around bal seal/nut retainer.Error still persists.
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 - (b)(4).G.1 - manufacturing site contact - (b)(4).H.6 - imdrf annex f code- f26.Investigation summary: based on the investigation results, the reported issue of tube not pressurized was confirmed.The potential cause was determined to be due to damage to fittings over time in the bal seal assembly.Fse completed the repair and 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 that bd facscanto¿ ii system w/fluidics cart tube could not pressurize.The following information was provided by the initial reporter: customer reported error tube could not pressurize.Check wet cart pressure is ok at 65, error occur while using loader.Lifter rod is clean, customer check drawer is properly locked into position.There were no broken wires in the cable beam from the loader.Customer also tried replace bal seal, no damage found on the sit area around bal seal/nut retainer.Error still persists.

• 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: 18016548
• Report Number: 2916837-2023-00207
• Device Sequence Number: 7638184
• Product Code: OYE
• UDI-Device Identifier: 00382903389629
• UDI-Public: 00382903389629
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• 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: Other,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/26/2024

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: 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: Not provided
• Supplement Date Received by Manufacturer: 06/26/2024
• Initial Report FDA Received Date: 10/26/2023
• Supplement Report FDA Received Date: 06/26/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/01/2016
• 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