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	12/23/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A device evaluation 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 slideprep, contamination was observed on the slides.The contamination possibly originated from the di water bottle.There were no health impact or consequences reported.
Additional Manufacturer Narrative
Investigation summary: the complaint alleges contamination (catalog number 491346, serial number (b)(6)).It was reported by the customer that the green specs have been see on slides.Service replaced all tubing entire rail syringes reagent station and lines from reagent station to syringes quad bundles and tubing on rail and tested.Based on service investigation, the complaint is confirmed and the root cause is attributed to contamination.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.Service history review revealed one complaint for similar root cause attributes.Samples were not received by quality for investigation and thus, returned material investigation could not occur.No new trends, risks, or hazards were identified as a result of the complaint.Bd quality will continue to closely monitor for trends associated with this complaint.
Event or Problem Description
It was reported while testing with bd totalys slideprep, contamination was observed on the slides.The contamination possibly originated from the di water bottle.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: matt j. connor ; 7 loveton circle; sparks, MD 21152 ; 4103164000
• MDR Report Key: 21201270
• Report Number: 1119779-2025-00012
• Device Sequence Number: 15329399
• Product Code: MKQ
• UDI-Device Identifier: 00382904913465
• UDI-Public: (01)00382904913465(11)171018
• Combination Product (Y/N): N
• Initial Reporter State: IA
• 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,Followup
• Report Date (Section B): 01/27/2025

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?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/23/2024
• Supplement Date Received by Manufacturer: 01/27/2025
• Initial Report FDA Received Date: 01/21/2025
• Supplement Report FDA Received Date: 02/26/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/18/2017
• 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