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

Catalog Number	443327
Medical Device Problem Code	Contamination (1120)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/14/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H.3.A device evaluation and/or device history review is anticipated but is not complete.Upon completion, a supplemental report will be filed.
Event or Problem Description
It was reported that while using bd totalys multiprocessor there is cross-contamination of the instrument causing an increased leukocyte count.No patient impact reported.The following information was provided by the initial reporter: "we have noticed that our samples got a lot of leukocytes the last few weeks.The amount of leukocytes on a slide is related to the sample itself.Most of the leukocytes are removed during the cell enrichment process in the multiprocessor.It did not concern erroneous results ¿ just messy results; obstructed with undesired cells.".
Event or Problem Description
It was reported that while using bd totals multiprocessor there is cross-contamination of the instrument causing an increased leukocyte count.No patient impact reported.The following information was provided by the initial reporter: "we have noticed that our samples got a lot of leukocytes the last few weeks.The amount of leukocytes on a slide is related to the sample itself.Most of the leukocytes are removed during the cell enrichment process in the multiprocessor.It did not concern erroneous results ¿ just messy results; obstructed with undesired cells.".
Additional Manufacturer Narrative
It has been determined that mdr 1119779-2023-00825 was reported in error.There was no report of cross contamination.It did not concern erroneous results ¿ just messy results; obstructed with undesired cells.There was no report of serious injury, medical intervention, or reportable device malfunction, hence the event should be considered not reportable.

• Brand Name: BD TOTALYS MULTIPROCESSOR
• Common Device Name: 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: jennifer suh ; 5859 farinon drive; san antonio, TX 78249 ; 8448235433
• MDR Report Key: 17440548
• Report Number: 1119779-2023-00825
• Device Sequence Number: 16822126
• Product Code: MKQ
• UDI-Device Identifier: 00382904433277
• UDI-Public: 00382904433277
• Combination Product (Y/N): N
• Initial Reporter Country: NO
• PMA/510(K) Number: P970018
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/09/2023

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
• Operator of Device: Other
• Device Catalogue Number: 443327
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/14/2023
• Supplement Date Received by Manufacturer: 08/08/2023
• Initial Report FDA Received Date: 08/02/2023
• Supplement Report FDA Received Date: 08/09/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/17/2018
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown