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	11/09/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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 while testing with bd prepstain¿, contamination was found.There was no report of patient impact.The following information was provided by the initial reporter: customer reports contamination on slides.
Additional Manufacturer Narrative
H.6.Investigation: complaint reports contamination on prepstain (catalog number 490100) serial number (b)(6).Complaint alleges instrument has contamination on slides.Results were not reported out to physicians and no improper treatment occurred.Service found the hematoxylin syringe with dried residue.Service cleaned and decontaminated the prepstain system and the vacuum pump.Service preformed a random xyz test and a tip handling test.A test run was performed, and no contamination was found.Post intervention the instrument was left operating normally.Root cause is attributed to poor cleaning.This complaint is not a confirmed failure of the instrument due to improper cleaning by customer caused the contamination.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 (b)(6) 2019.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 "contamination / foreign matter.".
Event or Problem Description
It was reported while testing with bd prepstain¿, contamination was found.There was no report of patient impact.The following information was provided by the initial reporter: customer reports contamination on slides.

• 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: 12937197
• Report Number: 1119779-2021-01914
• Device Sequence Number: 5085311
• 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
• Report Date (Section B): 03/01/2022

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: 11/09/2021
• Supplement Date Received by Manufacturer: 03/01/2022
• Initial Report FDA Received Date: 12/06/2021
• Supplement Report FDA Received Date: 03/08/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/10/2019
• 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