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

Catalog Number	490100
Medical Device Problem Code	Device Markings/Labelling Problem (2911)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/10/2026
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 after using bd prepstain slide processor, the serial number on the instrument was a duplicate to another instrument in the service system.No adverse impact was reported regarding the patient or user.
Additional Manufacturer Narrative
Correction description: after further evaluation of the complaint, it has been determined that the previously submitted report 1119779-2026-00344 was sent in error.Additional information was provided by the field service engineer, who stated that there were no new product issues.This event was previously reported via mfr# 1119779-2025-01740.
Event or Problem Description
Cancellation, see h11 for description.

• Brand Name: BD PREPSTAIN SLIDE PROCESSOR
• 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: 24557606
• Report Number: 1119779-2026-00344
• Device Sequence Number: 18357861
• Product Code: MKQ
• UDI-Device Identifier: 00382904901004
• UDI-Public: (01)00382904901004
• Combination Product (Y/N): N
• Initial Reporter Country: PL
• 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): 03/24/2026

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: 490100
• 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: 02/10/2026
• Supplement Date Received by Manufacturer: 03/24/2026
• Initial Report FDA Received Date: 03/10/2026
• Supplement Report FDA Received Date: 03/26/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/17/2016
• 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