MAUDE Adverse Event Report: BECTON DICKINSON & CO. (SPARKS) ROVERS® CERVEX-BRUSH® COMBI; SPATULA, CERVICAL, CYTOLOGICAL

Catalog Number	491462
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/03/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported while using combi-brush rovers (500 each) there was a swab tip/shaft break for one brush during a pap smear on one patient.No adverse impact was reported regarding the patient or the 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.
Event or Problem Description
It was reported while using combi-brush rovers (500 each) there was a swab tip/shaft break for one brush during a pap smear on one patient.No adverse impact was reported regarding the patient or the user.
Additional Manufacturer Narrative
Investigation summary: the customer complaint is for one brush becoming dislodged from the handle of item number 491462 lot 41403.Material 491462 is purchased from an approved supplier and shipped to a bd facility in baltimore, md where it is dispositioned by qc prior to customer distribution.A review for quality notifications (i.E., inspection failures) for 491462 lot 41403 identified no issues.A retain analysis could not be conducted because retain samples of this product are not kept by bd.No sample was returned, and no pictures were provided.Therefore, no return analysis could be performed.The complaint is not confirmed.A twelve-month complaint review was performed and identified prior complaints for the brush becoming dislodged from the handle.Complaints are trended at the mebane, nc facility and trigger levels have not been met.Therefore, no capa initiation determination (cid) or corrective or preventative action (capa) has been initiated for the issue.Bd quality will continue to monitor and trend events related to this issue to determine if corrective actions are required.

• Brand Name: ROVERS® CERVEX-BRUSH® COMBI
• Common Device Name: SPATULA, CERVICAL, CYTOLOGICAL
• 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: 21720632
• Report Number: 1119779-2025-00226
• Device Sequence Number: 18326594
• Product Code: HHT
• UDI-Device Identifier: 08719189246490
• UDI-Public: (01)08719189246490(11)210617(17)240501(10)41403
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• PMA/510(K) Number: K043369
• 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): 04/29/2025

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 Expiration Date: 05/01/2024
• Device Catalogue Number: 491462
• Device Lot Number: 41403
• 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: 03/04/2025
• Supplement Date Received by Manufacturer: 04/29/2025
• Initial Report FDA Received Date: 03/28/2025
• Supplement Report FDA Received Date: 05/09/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/17/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• 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