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

Model Number 491346

Device Problem Contamination (1120)

Patient Problems No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/14/2021

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.(b)(4).

Event Description

It was reported that while using bd totalys slideprep cross contamination was observed by the laboratory personnel.Cross contamination could lead to a false positive result which might lead to unnecessary follow up.There was no report of patient impact.

Event Description

It was reported that while using bd totalys slideprep cross contamination was observed by the laboratory personnel.Cross contamination could lead to a false positive result which might lead to unnecessary follow up.There was no report of patient impact.

Manufacturer Narrative

Investigation summary: complaint reports staining issue on slideprep (catalog number 491346) serial number (b)(6).Complaint alleges first few samples had a mixture of mold smeared on the surface.Service found that some mold remained in the purified water diti tubing.This was the first operation after the end of the year, customer stated they emptied the purified water and cleaned the tubing prior to the end of the year.During the starting process one priming cycle did not clear the tubing of the mold, service recommended to perform two priming cycle¿s after any extended pause of use.Post intervention, instrument was left operating normally.Root cause is attributed to user error.Compliant is not confirmed due to cleaning error by user.Dhr review revealed no abnormalities during build and test of this unit prior to shipping, as it is related to the failure mode reported.There are no corrective action plans or other corrections occurring.Bd quality will continue to monitor for trends associated with failure of "staining.".

• 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
• MDR Report Key: 11282434
• MDR Text Key: 239004633
• Report Number: 1119779-2021-00249
• Device Sequence Number: 1
• Product Code: MKQ
• UDI-Device Identifier: 00382904913465
• UDI-Public: 00382904913465
• Combination Product (y/n): N
• PMA/PMN Number: P970018
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,other,user facility
• Type of Report: Initial,Followup
• Report Date: 07/26/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/04/2021
• 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
• Date Manufacturer Received: 07/26/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1