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

Catalog Number	491346
Medical Device Problem Code	Excessive Heating (4030)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/13/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The complaint alleges the slideprep instrument (catalog number 491346 and serial number (b)(6) had heater firmware errors.Customer reported heater 3 failure, when pulling out the slide tray they noticed some heat which made the index finger become red.Customer confirmed the superficial burn subsided without any treatment.Service replaced heater module and verified no issues or errors; the instrument was turned back over to the customer for normal use.This complaint is a confirmed failure of the instrument, and the root cause can be attributed to a faulty heater module.Review of device history record for this instrument 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.Quality did receive sample; heater was plugged into the slideprep test bed and confirmed the heater heats up on its own.The heater is only supposed to heat up when commanded to thru the software application.Then the heater was taken apart and found the internal heater board had faulty components which could have caused this issue.Q1 and q2 components have burnt markings.These components control the heating element of the heater; visual inspection no other components showed any defect.The heaters are not used during the cytology application and a heater bypass kit is available to upgrade any units in the field.Bd quality will continue to monitor trends associated with the failure mode described in this complaint.
Event or Problem Description
It was reported while using bd totalys slideprep, it was discovered while performing the product investigation that the user experienced a burn to their finger when pulling out the slide tray due to a heater error.The user experienced redness in the finger, but the condition calmed days later and user was able to recover fully without treatment.No adverse impact was reported regarding the patient.

• 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: matt j. connor ; 7 loveton circle; sparks, MD 21152 ; 4103164000
• MDR Report Key: 23406542
• Report Number: 1119779-2025-05190
• Device Sequence Number: 15719833
• Product Code: MKQ
• UDI-Device Identifier: 00382904913465
• UDI-Public: (01)00382904913465(11)200303
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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
• Report Date (Section B): 10/28/2025

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: 491346
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/17/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/24/2025
• Initial Report FDA Received Date: 10/28/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/03/2020
• 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