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

Catalog Number 443327

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

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

Event Date 02/23/2024

Event Type  malfunction  

Event Description

It was reported when using the bd totalys multiprocessor the user was unable to use the barcode scanner of the device therefore manual entry of patient information was required.The user inadvertently entered the patient information incorrectly for two patients, swapping one for the other.The error was caught allowing the user to correct the error.No health impact or consequence reported.

Manufacturer Narrative

H6: investigation summary: complaint reports mis association on multiprocessor (catalog number 443327) serial number (b)(6).Complaint alleges user error; the instrument was unable to read a barcode and requested the user input the barcode manually.User incorrectly input the barcode, thus causing a potential sample inversion.User started the process over with the correct barcode entry.No erroneous results were reported.Root cause attributed to user error.This complaint is not a confirmed failure of the instrument based on the service investigation.Review of device history record 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.Service history review was performed, 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.There are no corrective action plans or other corrections occurring.Bd quality will continue to monitor for trends associated with failure of "misassociation.".

• Brand Name: BD TOTALYS MULTIPROCESSOR
• 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: jo doyka ; 7 loveton circle; sparks, MD 21152 ; 4103164000
• MDR Report Key: 18912681
• MDR Text Key: 337762854
• Report Number: 1119779-2024-00208
• Device Sequence Number: 1
• Product Code: MKQ
• UDI-Device Identifier: 00382904433277
• UDI-Public: (01)00382904433277
• Combination Product (y/n): N
• Reporter Country Code: FR
• 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
• Report Date: 02/28/2024

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
• Device Operator: Other
• Device Catalogue Number: 443327
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/23/2024
• Initial Date FDA Received: 03/15/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/28/2014
• 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