MAUDE Adverse Event Report: BECTON DICKINSON & CO. (SPARKS) BD PREPSTAIN SLIDE PROCESSOR; MICROSCOPE SLIDE MAKER/STAINER IVD

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	06/12/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
D.4.Medical device expiration date: unknown 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 prepstain tecan us ii, the serial number on the instrument was incorrect.It was found that the serial number of the instrument is a duplicate serial number to another instrument in the field.No adverse impact was reported regarding the patient or user.
Event or Problem Description
It was reported after using prepstain tecan us ii, the serial number on the instrument was incorrect.It was found that the serial number of the instrument is a duplicate serial number to another instrument in the field.No adverse impact was reported regarding the patient or user.
Additional Manufacturer Narrative
Investigation summary- introduction the complaint alleges labeling issues associated with the prepstain instrument (catalog number 490100 serial number tps0020).Customer interlux reached out to our helpdesk team to help with resolving issue, described in wo-04015738.After investigation it turned out, that we don't have this sn sold/shipped to 6050 market (lithuania).Instrument with the exact sn is currently located in lublin (poland) as reagent rental.Material #: 490100 serial #:(b)(6) returned material analysis no physical samples were received as part of this complaint; however, photographs of the issue were provided and reviewed, confirming no issue with poland prepstain instrument investigational testing/ review investigation revealed this case is related to another instrument with the same s/n tps0020.The other instrument is installed in lithuania (kaunas) and under control of the local distributor.Communications with this distributor has revealed no traceability to their installed instrument.In poland (lublin- this device is fully traceable) and in lithuania (kaunas- origin of this device cannot be traced).Poland instrument was released back to customer for normal use.Service history review revealed no previous complaints for this issue.Conclusion / outcome complaint is an unconfirmed failure of the instrument.The root cause cannot be determined with the information provided.Review of risk management files confirms there are no new or modified risks associated with this failure mode.Complaints received for this device and reported condition will continue to be tracked and trended.Information will be captured on trend reports and monitored.

• Brand Name: BD PREPSTAIN SLIDE PROCESSOR
• Common Device Name: MICROSCOPE SLIDE MAKER/STAINER IVD
• 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: 22473405
• Report Number: 1119779-2025-01740
• Device Sequence Number: 14477381
• 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: Foreign,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 07/09/2025

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: 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: 06/13/2025
• Initial Report FDA Received Date: 07/10/2025
• 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