MAUDE Adverse Event Report: BECTON DICKINSON & CO. (SPARKS) INSTRUMENT BD TOTALYS MULTIPROCESSO

Catalog Number	443327
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	03/22/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Investigation summary: complaint reports slide mismatch failure on multiprocessor (catalog number 443327) serial number (b)(6).Complaint alleges cytologist looked at four slides and noticed they were mismatched.Service had customer reprocess the samples manually using the prepmate and slideprep.Cytologist compared the slides of the manually processed and slides processed with the multiprocessor and they matched.In conclusion the multiprocessor operates normally.Root cause not determined, and this complaint is not a confirmed failure of the instrument based on the service investigation.Review of device history record for instrument serial number, (b)(6) is not required because this complaint does not allege an early life failure or failure at installation and has changed configuration since release from manufacturing due to service repairs/pms.Device was installed on (b)(6) 2020.Service history review was performed for the instrument (b)(6), and no additional work orders were observed for the complaint failure mode reported.Review of risk management files confirms there are no new or modified risks associated with this failure mode.There are no corrective action plans or other corrections occurring.Bd quality will continue to monitor for trends associated with failure of "misassociation." this mdr is being submitted as part of a retrospective review of records dating april 2023-2025, under capa 11910483.
Event or Problem Description
It was reported while using instrument bd totalys multiprocessor, patient data was incorrectly associated with another patient.There was no report of patient impact.
Event or Problem Description
It was reported while using instrument bd totally multiprocessor, patient data was incorrectly associated with another patient.There was no report of patient impact.
Additional Manufacturer Narrative
This mdr was previously submitted as part of a retrospective review of records dating april 2023-2025, under capa 11910483.After additional review, it was determined that no additional mdrs were required for this malfunction.This mdr should be considered cancelled.

• Brand Name: INSTRUMENT BD TOTALYS MULTIPROCESSO
• Common Device Name: NA
• Manufacturer (Section D): BECTON DICKINSON & CO. (SPARKS); 7 loveton circle; sparks MD 21152
• Manufacturer (Section G): BECTON, DICKINSON & CO. (SPARKS); 7 loveton circle; sparks MD 21152
• Manufacturer Contact: matt j. connor ; 7 loveton circle; sparks, MD 21152 ; 4103164000
• MDR Report Key: 22886320
• Report Number: 1119779-2025-04329
• Device Sequence Number: 4849451
• Product Code: MKQ
• UDI-Device Identifier: 00382904433277
• UDI-Public: (01)00382904433277(11)191205
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: P970018
• 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): 08/14/2025

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: 443327
• 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: 03/30/2023
• Supplement Date Received by Manufacturer: 09/29/2025
• Initial Report FDA Received Date: 08/25/2025
• Supplement Report FDA Received Date: 10/21/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/05/2019
• 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