MAUDE Adverse Event Report: BECTON DICKINSON & CO. (SPARKS) BD TOTALYS MULTIPROCESSOR; PROCESSOR, CERVICAL CYTOLOGY SLIDE, AUTOMATED

Catalog Number	443327
Medical Device Problem Code	Structural Problem (2506)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/21/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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 while testing with bd totalys multiprocessor, the centrifuge lid was free-falling due to springs being worn out.There were no health impact or consequences reported.
Event or Problem Description
It was reported while testing with bd totalys multiprocessor, the centrifuge lid was free-falling due to springs being worn out.There were no health impact or consequences reported.
Additional Manufacturer Narrative
Investigation summary - complaint reports centrifuge lid issues on multiprocessor (catalog number 443327) serial number (b)(6).Complaint alleges instrument centrifuge gas springs can no longer support the weight of the lid.Service replaced the centrifuge lid gas springs, performed a functional test; instrument was turned back over to the customer for normal use.This complaint is a confirmed failure of the instrument, and the root cause cannot be determined with the information provided.Review of device history record for instrument (b)(6) is not required as this complaint does not allege an early life failure or failure at install of the instrument.Service history review was performed, and no additional work orders were observed for the complaint failure mode reported.No samples were expected to be received as part of this complaint, and therefore no samples were returned, and no returned material investigation could occur.Bd quality will continue to monitor for trends associated with the failure mode described in this complaint.

• Brand Name: BD TOTALYS MULTIPROCESSOR
• Common Device Name: PROCESSOR, CERVICAL CYTOLOGY SLIDE, AUTOMATED
• 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: 21422317
• Report Number: 1119779-2025-00090
• Device Sequence Number: 7781879
• Product Code: MKQ
• UDI-Device Identifier: 00382904433277
• UDI-Public: (01)00382904433277(11)140428
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• 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: Other,Foreign,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/13/2025

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: 01/21/2025
• Supplement Date Received by Manufacturer: 03/13/2025
• Initial Report FDA Received Date: 02/20/2025
• Supplement Report FDA Received Date: 04/08/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/28/2014
• 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