MAUDE Adverse Event Report: BECTON, DICKINSON & CO. (SPARKS) BD ROVERS® CERVIX-BRUSH®; PROCESSOR, CERVICAL CYTOLOGY SLIDE, AUTOMATED

Catalog Number	491461
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/28/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that while using bd rovers® cervix-brush® that there was a swab break.The following information was provided by the initial reporter: was there any patient impact?- "no long term harm- only from needing to be removed s/p being dislodged." customer reports that cytobrush dislodged from stem for cat 491461 lot 41099.
Additional Manufacturer Narrative
E.1 initial reporter addr 1: (b)(6).H.3.A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.
Additional Manufacturer Narrative
H.6 investigation summary the customer complaint is for one brush becoming dislodged from the handle of item number 491461 lot 41099.The customer stated that the patient¿s procedure was able to be completed and the brush head was removed.Material 491461 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 491461 lot 41099 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 one prior complaint for the brush becoming dislodged from the handle of item number 491461.Complaints are trended at the mebane, nc facility and trigger levels have not been met.
Event or Problem Description
It was reported that while using bd rovers® cervix-brush® that there was a swab break.The following information was provided by the initial reporter: was there any patient impact?- "no long term harm- only from needing to be removed s/p being dislodged" customer reports that cytobrush dislodged from stem for cat 491461 lot 41099.

• Brand Name: BD ROVERS® CERVIX-BRUSH®
• 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: jennifer suh ; 7 loveton circle; sparks, MD 21152 ; 4103164000
• MDR Report Key: 18026025
• Report Number: 1119779-2023-01190
• Device Sequence Number: 15346578
• Product Code: HHT
• UDI-Device Identifier: 08719189246483
• UDI-Public: (01)08719189246483
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: K930955
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/13/2024

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: 02/01/2024
• Device Catalogue Number: 491461
• Device Lot Number: 41099
• 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: 09/29/2023
• Supplement Date Received by Manufacturer: 02/13/2024
• Initial Report FDA Received Date: 10/27/2023
• Supplement Report FDA Received Date: 03/06/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/08/2021
• 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