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

Model Number 491346

Device Problem Contamination (1120)

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

Event Date 12/13/2022

Event Type  malfunction  

Event Description

It was reported that bd totalys slideprep contamination is occurring.The following information was provided by the initial reporter: contamination is occurring.

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 contamination is occurring.The following information was provided by the initial reporter: contamination is occurring.

Manufacturer Narrative

H.6 investigation summary: complaint reports contamination on slideprep (catalog number 491346) serial number (b)(6).Complaint alleges instrument contamination due to bundle touching slides, no erroneous results were reported.Service adjusted the quad bundle z max height and realigned the quad arm.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, ppla300112 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 09/24/2013.Service history review was performed for the instrument ppla300112, 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.

• 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: 16142695
• MDR Text Key: 308079364
• Report Number: 1119779-2023-00022
• Device Sequence Number: 1
• Product Code: MKQ
• UDI-Device Identifier: 00382904913465
• UDI-Public: 00382904913465
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: P970018
• 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: 02/14/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/11/2023
• 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: 02/14/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/14/2014
• 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