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

Catalog Number 491461

Device Problem Break (1069)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 07/28/2023

Event Type  malfunction  

Event Description

It was reported that while using bd rovers® cervix-brush®, the brush handle came off during the procedure.No patient impact reported.The following information was provided by the initial reporter: "reports that the brush handle came off during the procedure.Was there any harm/injury to the patient due to the problem? - answer: there was no damage.The nurse only had to call another nurse to help with the collection when the brush came loose.".

Manufacturer Narrative

H.3.A device evaluation and/or device history review is anticipated but is not complete.Upon completion, a supplemental report will be filed.

Event Description

It was reported that while using bd rovers® cervix-brush®, the brush handle came off during the procedure.No patient impact reported.The following information was provided by the initial reporter: "reports that the brush handle came off during the procedure.Was there any harm/injury to the patient due to the problem? answer: there was no damage.The nurse only had to call another nurse to help with the collection when the brush came loose.".

Manufacturer Narrative

H.6 investigation summary the customer complaint is for one brush becoming dislodged from the handle of item number 491461 lot 41690.The customer stated that the patient¿s procedure was able to be completed and did not result in recollection.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 41690 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 no prior complaints for the brush becoming dislodged from the handle of item number 491461.

• Brand Name: BD ROVERS® CERVIX-BRUSH®
• Type of Device: 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 ; 5859 farinon drive; san antonio, TX 78249 ; 8448235433
• MDR Report Key: 17611542
• MDR Text Key: 321937340
• Report Number: 1119779-2023-00932
• Device Sequence Number: 1
• Product Code: HHT
• Combination Product (y/n): N
• Reporter Country Code: BR
• PMA/PMN Number: K930955
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 02/13/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/24/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 491461
• Device Lot Number: 41690
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/13/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/09/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1