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	02/04/2022
Type of Reportable Event	Malfunction
Additional 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 or Problem Description
It was reported when using the bd prepstain¿ there was cross contamination.There was no report of adverse patient impact.The following information was provided by the initial reporter.The customer stated: "the instrument was dropping specimens.No wrong results were reported to the doctors.No patients were treated based on the results.Samples are not being processed and workflow is not being maintained.".
Additional Manufacturer Narrative
H6: investigation summary bd quality has reviewed the complaint, service activities, and adverse event questions.The results of this evaluation have not identified any new hazards, new risks, or specific trends.Complaints received for this device and reported condition will continue to be tracked and trended.Additional investigation will be performed if an actionable level is reached.Dhr/bhr review is not required for this complaint.The complaint was evaluated via other elements of the investigation.The results of this evaluation have not identified any new hazards, new risks, or specific trends.H3 other text : see h10.
Event or Problem Description
It was reported when using the bd prepstain¿ there was cross contamination.There was no report of adverse patient impact.The following information was provided by the initial reporter.The customer stated: "the instrument was dropping specimens.No wrong results were reported to the doctors.No patients were treated based on the results.Samples are not being processed and workflow is not being maintained.".
Additional Manufacturer Narrative
H.6.Investigation: complaint reports leaking issues on prepstain (catalog number 490100) serial number (b)(6).Complaint alleges specimen dripping from diti, no erroneous results or wrong treatment were reported.Service replaced the diti cone grip and realigned the diti.Post intervention the instrument was left operating normally.Root cause is attributed to a faulty diti assembly.This complaint is a confirmed failure of the instrument based on the service investigation.Review of device history record for instrument serial number, (b)(6) is not required because this complaint does not allege an early life failure or failure at installation and has changed configuration since release from manufacturing due to service repairs/pms.Device was installed on 07/25/2013.Service history review was performed for the instrument (b)(6), and no additional work orders were observed for the complaint failure mode reported.Review of risk management files confirms there are no new or modified risks associated with this failure mode.There are no corrective action plans or other corrections occurring.Bd quality will continue to monitor for trends associated with failure of "diti errors.".
Event or Problem Description
It was reported when using the bd prepstain¿ there was cross contamination.There was no report of adverse patient impact.The following information was provided by the initial reporter.The customer stated: "the instrument was dropping specimens.No wrong results were reported to the doctors.No patients were treated based on the results.Samples are not being processed and workflow is not being maintained.".

• 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: phillip emmert ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 13655086
• Report Number: 1119779-2022-00344
• Device Sequence Number: 20271241
• Product Code: MKQ
• UDI-Device Identifier: 00382904901004
• UDI-Public: 00382904901004
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• 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,Followup
• Report Date (Section B): 04/29/2022

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: 02/04/2022
• Supplement Date Received by Manufacturer: 03/17/2022; 04/29/2022
• Initial Report FDA Received Date: 03/02/2022
• Supplement Report FDA Received Date: 03/19/2022; 05/06/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/26/2016
• Is the Device Labeled for Single Use? (Y/N): Yes
• 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