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

Catalog Number	657338
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/12/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
D.4.Medical device expiration date: na.E.1.Initial reporter phone#: (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 the loader cover was broken and accessed by the user on the bd facscanto¿.The following information was provided by the initial reporter: the issue was resolved via mailed cover (338709) to customer and replaced by customer themselves.The instrument runs normally.Facscanto plus- the cover of loader is broken.
Additional Manufacturer Narrative
After further evaluation of the complaint, it has been determined that the previously submitted report 2916837-2023-00155 was sent in error.There was no report of serious injury, medical intervention, or reportable device malfunction.Therefore this is not considered to be a reportable malfunction.
Event or Problem Description
It was reported that the loader cover was broken and accessed by the user on the bd facscanto¿.The following information was provided by the initial reporter: the issue was resolved via mailed cover (338709) to customer and replaced by customer themselves.The instrument runs normally.Facscanto plus- the cover of loader is broken.

• Brand Name: BD FACSCANTO¿
• 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: jennifer suh ; 9450 south state street; sandy, UT 84070 ; 8448235433
• MDR Report Key: 17435392
• Report Number: 2916837-2023-00155
• Device Sequence Number: 15162206
• Product Code: OYE
• UDI-Device Identifier: 00382906573384
• UDI-Public: 00382906573384
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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: Foreign,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/23/2023

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: 657338
• 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: 07/12/2023
• Supplement Date Received by Manufacturer: 07/25/2023
• Initial Report FDA Received Date: 08/01/2023
• Supplement Report FDA Received Date: 08/24/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/29/2016
• 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