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

Model Number 491346

Device Problem Microbial Contamination of Device (2303)

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

Event Date 03/01/2021

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 while using bd totalys slideprep cross-contamination occurred.Fungi on 1st tray was found on 4th tray.There was no reported patient impact.

Manufacturer Narrative

H.6.Investigation: complaint reports fungi contamination issue on slideprep (catalog number 491346) serial number (b)(6).Complaint alleges fungi on the first tray were found on the fourth tray.It was observed that the nozzle did not contact the slide.No erroneous results were reported.Service communicated cells remaining on the nozzle could attach to another tip.Service had the customer clean the nozzle and communicated that the cleaning needs to take place once a week.Post intervention the instrument was left operating normally.Root cause is not determined and this complaint is not a confirmed failure of the instrument.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." h3 other text : see h.10.

Event Description

It was reported while using bd totalys slideprep cross-contamination occurred.Fungi on 1st tray was found on 4th tray.There was no reported patient impact.

• 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: 11517438
• MDR Text Key: 243645823
• Report Number: 1119779-2021-00507
• 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: 08/19/2021

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
• Initial Date Manufacturer Received: 03/01/2021
• Initial Date FDA Received: 03/18/2021
• Supplement Dates Manufacturer Received: 09/23/2021
• Supplement Dates FDA Received: 09/23/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1