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

Catalog Number	491346
Medical Device Problem Code	Structural Problem (2506)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/28/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Investigation summary: complaint reports lid failure on centrifuge associated with slideprep (catalog number 491346) serial number (b)(6).Complaint alleges centrifuge lid is no longer being held up properly, faulty lid hydraulic system.Customer advised no one was hurt or injured.Service replaced the centrifuge gas springs and post intervention the centrifuge was operating normally.Root cause attributed to faulty lid gas springs.This complaint is a confirmed failure of the instrument based on the customer investigation.Device history record review is not required because the part that allegedly failure is not tested as part of the manufacturing process but is shipped separately and tested during installation.Service history review was performed for the instrument 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.Review of risk management files confirm 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 "centrifuge.
Event or Problem Description
It was reported when using the bd totals slide prep, the shocks for the centrifuge lid were no longer holding the lid open.There were no health impact or consequences reported.

• Brand Name: BD TOTALYS SLIDEPREP
• 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: jo doyka ; 7 loveton circle; sparks, MD 21152 ; 4103164000
• MDR Report Key: 20322837
• Report Number: 1119779-2024-00695
• Device Sequence Number: 7630637
• Product Code: MKQ
• UDI-Device Identifier: 00382904913465
• UDI-Public: (01)00382904913465(11)180109
• Combination Product (Y/N): N
• Initial Reporter State: MN
• 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: Other,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 08/30/2024

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: 491346
• 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: 08/28/2024
• Initial Report FDA Received Date: 09/27/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/09/2018
• Is the Device Labeled for Single Use? (Y/N): Yes
• 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