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

Catalog Number	491346
Medical Device Problem Code	Contamination (1120)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/23/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H3.A device evaluation is anticipated but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.
Event or Problem Description
It was reported that during use with the bd totalys slideprep, there was suspected cross contamination of samples.No patient impact was reported.
Event or Problem Description
It was reported that during use with the bd totals slide-prep, there was suspected cross contamination of samples.No patient impact was reported.
Additional Manufacturer Narrative
Complaint reports cross contamination on slide-prep (catalog number 491346) serial number (b)(6).Complaint alleges possible cross contamination; no erroneous results were recorded.Service checked for vacuum issue and quad bundle damage; no issues were detected.Service performed a water run, random xyz test, and a tip pickup test without any issues or errors.Instrument is working 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 01/24/2013.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.H3 other text : see h.10.

• 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: 18355304
• Report Number: 1119779-2023-01381
• Device Sequence Number: 12456280
• Product Code: MKQ
• UDI-Device Identifier: 00382904913465
• UDI-Public: (01)00382904913465
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• 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,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/22/2023

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: 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: 11/23/2023
• Supplement Date Received by Manufacturer: 12/22/2023
• Initial Report FDA Received Date: 12/19/2023
• Supplement Report FDA Received Date: 01/18/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/19/2016
• 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