MAUDE Adverse Event Report: BECTON DICKINSON & CO. (SPARKS) BD FOCALPOINT¿ SLIDE PROFILER REFURBISHED; CELL MORPHOLOGY ANALYSER IVD, MANUAL

Catalog Number	491090
Medical Device Problem Code	False Negative Result (1225)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/15/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported after using bd focalpoint¿ slide profiler refurbished there was one false negative result.Initially, no abnormal cells were located in the field of vision, but after qc review, atypical cells were found outside the field of vision.No adverse impact was reported regarding the patient or user.
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.

• Brand Name: BD FOCALPOINT¿ SLIDE PROFILER REFURBISHED
• Common Device Name: CELL MORPHOLOGY ANALYSER IVD, MANUAL
• 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: 24225288
• Report Number: 1119779-2026-00032
• Device Sequence Number: 8392365
• Product Code: MNM
• UDI-Device Identifier: 00382904910907
• UDI-Public: (01)00382904910907
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: P950009
• 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
• Report Date (Section B): 01/19/2026

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: 491090
• 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: 01/15/2026
• Initial Report FDA Received Date: 01/30/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/02/2022
• 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