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

Model Number	490100
Medical Device Problem Code	Contamination (1120)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/28/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A device evaluation and/or device history review is anticipated, but is not complete.Upon completion, a supplemental report will be filed.Medical device expiration date: na.
Event or Problem Description
It was reported that while using bd prepstain¿ contamination was observed by the laboratory personnel.There was no indication that results were reported out and there was no report of patient impact.The following information was provided by the initial reporter: "(b)(4): instrument prepstain tecan us ii: contamination".
Additional Manufacturer Narrative
H6: investigation summary: complaint reports contamination on prepstain (catalog number 490100) serial number (b)(6).Complaint alleges contamination on prepstain instrument.Service tried multiple times to contact the customer to find out information concerning the contamination.No response from the customer.Root cause is not determined, and this complaint is not a confirmed failure of the instrument as no material was returned for 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.
Event or Problem Description
It was reported that while using bd prepstain¿ contamination was observed by the laboratory personnel.There was no indication that results were reported out and there was no report of patient impact.The following information was provided by the initial reporter: " 490100 - instrument prepstain tecan us ii - contamination.".

• Brand Name: BD PREPSTAIN¿
• 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: katie swenson ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 12700712
• Report Number: 1119779-2021-01716
• Device Sequence Number: 3751141
• Product Code: MKQ
• UDI-Device Identifier: 00382904901004
• UDI-Public: 00382904901004
• Combination Product (Y/N): N
• Initial Reporter Country: RE
• 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): 03/02/2022

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
• Operator of Device: Other
• Device Model Number: 490100
• Device Catalogue Number: 490100
• 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: 09/28/2021
• Supplement Date Received by Manufacturer: 03/02/2022
• Initial Report FDA Received Date: 10/26/2021
• Supplement Report FDA Received Date: 03/08/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/01/2016
• 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