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

Model Number 491346

Device Problem Incorrect, Inadequate or Imprecise Result or Readings (1535)

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

Event Date 01/26/2023

Event Type  malfunction  

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 Description

It was reported that bd totalys slideprep carry over occurred from one case to another.The following information was provided by the initial reporter: customer reports a slide with light cellularity had a thick spot of cells, they believe in the area around where the quad tip vacuums.Customer said the slide to the left of this one had really thick cellularity.It was noticed the suspected carry over while screening so there were no erroneous reports sent out.

Manufacturer Narrative

H.6 investigation summary: complaint reports contamination on slideprep (catalog number 491346) serial number (b)(6).Complaint alleges slides contain thick spots of cells caused by quad bundle tips, no erroneous results were reported.Service replaced the quad bundle tips and realigned the quad arm parameters.Root cause attributed to misalignment of quad arm.This complaint is a confirmed failure of the instrument based on the service investigation.Review of device history record for instrument serial number, (b)(6) is not required because this complaint does not allege an early life failure or failure at installation and has changed configuration since release from manufacturing due to service repairs/pms.Device was installed on 09/25/2020.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 bd totalys slideprep carry over occurred from one case to another.The following information was provided by the initial reporter: customer reports a slide with light cellularity had a thick spot of cells, they believe in the area around where the quad tip vacuums.Customer said the slide to the left of this one had really thick cellularity.It was noticed the suspected carry over while screening so there were no erroneous reports sent out.

• 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 ; 8015296192
• MDR Report Key: 16383132
• MDR Text Key: 309661856
• Report Number: 1119779-2023-00138
• 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: 03/20/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/15/2023
• 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: 03/20/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/29/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1