MAUDE Adverse Event Report: BECTON, DICKINSON & CO. (SPARKS) INSTRUMENT PREPSTAIN TECAN US II REFURB

Model Number 490407

Device Problem Contamination (1120)

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

Event Date 02/02/2023

Event Type  malfunction  

Event Description

It was reported that while using the bd instrument prepstain tecan us ii refurb that there was cross-contamination.The following information was provided by the initial reporter: customer stains offline so cells outside cell circle are stained.Customer has determined that drips on top of slides are cross contamination from other samples.Customer does not screen these slides and reprocesses sample on a different slide.

Manufacturer Narrative

Common device name: processor, cervical cytology slide, automated.Initial reporter e-mail: (b)(6).A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.

Event Description

It was reported that while using the bd instrument prepstain tecan us ii refurb that there was cross-contamination.The following information was provided by the initial reporter: customer stains offline so cells outside cell circle are stained.Customer has determined that drips on top of slides are cross contamination from other samples.Customer does not screen these slides and reprocesses sample on a different slide.

Manufacturer Narrative

H.6 investigation summary: complaint reports contamination on prepstain (catalog number 490407) serial number (b)(6).Complaint alleges instrument intermittently drops a tip after sample transfer which occasionally drips on top edge of slides.Customer stated no erroneous results reported.Service replaced diti tubing and diti sleeve grip tip then performed a water run without any leaks or drips.Root cause attributed to worn diti grip tip.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 08/16/2011.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.There are no corrective action plans or other corrections occurring.Bd quality will continue to monitor for trends associated with failure of "contamination / foreign matter.".

• Brand Name: INSTRUMENT PREPSTAIN TECAN US II REFURB
• Type of Device: NA
• 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: 16450239
• MDR Text Key: 310382882
• Report Number: 1119779-2023-00173
• Device Sequence Number: 1
• Product Code: MKQ
• UDI-Device Identifier: 00382904904074
• UDI-Public: 00382904904074
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 03/24/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/27/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: 490407
• Device Catalogue Number: 490407
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/24/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/27/2014
• 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