MAUDE Adverse Event Report: TRIPATH IMAGING, INC BD TOTALYS¿ SLIDEPREP; AUTOMATED CERVICAL CYTOLOGY SLIDE PROCESSOR

Model Number 491346

Device Problem Contamination (1120)

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

Event Date 09/30/2021

Event Type  malfunction  

Manufacturer Narrative

Medical device expiration date: na.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 cross-contamination occurred while using the bd totalys¿ slideprep.The following information was provided by the initial reporter, translated from (b)(6) to english: "contamination is occurring".

Event Description

It was reported that cross-contamination occurred while using the bd totalys¿ slideprep.The following information was provided by the initial reporter, translated from japanese to english: "contamination is occurring".

Manufacturer Narrative

H6: investigation: complaint reports contamination on slideprep (catalog number 491346) serial number ppla300140.Complaint alleges contamination is occurring with the quad bundles.Service adjusted the quad height and performed cleaning on all four nozzles.Post intervention the instrument was left operating normally.Root cause is attributed to quad height.This complaint is a confirmed failure of the instrument base in the service investigation.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 "contamination / foreign matter.".

• Brand Name: BD TOTALYS¿ SLIDEPREP
• Type of Device: AUTOMATED CERVICAL CYTOLOGY SLIDE PROCESSOR
• Manufacturer (Section D): TRIPATH IMAGING, INC; 1022 corporate park drive; mebane NC 27302
• Manufacturer (Section G): TRIPATH IMAGING, INC; 1022 corporate park drive; mebane NC 27302
• Manufacturer Contact: katie swenson ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 12715907
• MDR Text Key: 284314491
• Report Number: 3008007472-2021-00005
• 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: NA
• 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: 03/03/2022

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 Model Number: 491346
• Device Catalogue Number: 491346
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/30/2021
• Initial Date FDA Received: 10/28/2021
• Supplement Dates Manufacturer Received: 03/03/2022
• Supplement Dates FDA Received: 03/09/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/08/2014
• 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