MAUDE Adverse Event Report: BECTON, DICKINSON & CO. (SPARKS) BD TOTALYS SLIDEPREP; PROCESSOR, CERVICAL CYTOLOGY SLIDE, AUTOMATED

Model Number 491346

Device Problem Structural Problem (2506)

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

Event Date 06/16/2023

Event Type  malfunction  

Event Description

It was reported that during use with the bd totalys slideprep, the centrifuge spins with the lid open.There was no report of patient or user impact.The following information was provided by the initial reporter: it was reported by the customer that when the centrifuge lid is closing there is a loud grinding noise, and the customer has to manually push the lid down to close it.They have to place a weight on the lid to keep it closed when the centrifuge is processing specimens.

Manufacturer Narrative

A device evaluation is anticipated but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.

Manufacturer Narrative

H.6.Investigation summary: complaint reports centrifuge lid issues associated with slideprep (catalog number 491346) serial number (b)(6).Complaint alleges a loud grinding noise while closing the centrifuge lid and customer must place a weight on the lid to keep it closed.Customer was sent a replacement centrifuge and confirmed the centrifuge is operating normally.Root cause is attributed to faulty lid latch.This complaint is a confirmed failure of the centrifuge based on customer investigation.Device history review is not required because the part that allegedly failed is not tested as part of the manufacturing process but is shipped separately and tested during installation.Service history review was performed for the instrument (b)(6), and no additional work orders were observed for the complaint failure mode reported.Review of risk management files confirms there are no new or modified risks associated with this failure mode.

Event Description

It was reported that during use with the bd totalys slideprep, the centrifuge spins with the lid open.There was no report of patient or user impact.The following information was provided by the initial reporter: it was reported by the customer that when the centrifuge lid is closing there is a loud grinding noise, and the customer has to manually push the lid down to close it.They have to place a weight on the lid to keep it closed when the centrifuge is processing specimens.

• Brand Name: BD TOTALYS SLIDEPREP
• 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: phillip emmert ; 9450 south state street; sandy, UT 84070 ; 8448235433
• MDR Report Key: 17204922
• MDR Text Key: 317907676
• Report Number: 1119779-2023-00712
• Device Sequence Number: 1
• Product Code: MKQ
• UDI-Device Identifier: 00382904913465
• UDI-Public: 00382904913465
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P970018
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 11/03/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/26/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: 491346
• Device Catalogue Number: 491346
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/03/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/30/2018
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1