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

Model Number	490407
Medical Device Problem Code	Contamination (1120)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/03/2022
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 that the bd prepstain¿ slide processor's specimen dripped out and created cross-contamination.As a result, the specimens had to be rerun.There was no indication that the erroneous results were reported to clinicians, and there was no report of adverse patient impact.The following information was provided by the initial reporter: "customer requesting dispatch due to dripping specimen.There was contamination." "were any pts treated based on erroneous results? no, when the cross contamination was seen, they reran the specimens.Did the wrong treatment harm the patient? no.".
Event or Problem Description
It was reported that the bd prepstain¿ slide processor's specimen dripped out and created cross-contamination.As a result, the specimens had to be rerun.There was no indication that the erroneous results were reported to clinicians, and there was no report of adverse patient impact.The following information was provided by the initial reporter: "customer requesting dispatch due to dripping specimen.There was contamination."."- were any pts treated based on erroneous results? no, when the cross contamination was seen, they reran the specimens.- did the wrong treatment harm the patient? no".
Additional Manufacturer Narrative
H.6.Investigation: complaint reports contamination on prepstain (catalog number 490407) serial number (b)(6).Complaint alleges instrument is dripping specimen, no erroneous results were reported and no harm to the patient.Service reconnected the diti tubing and then observed a completed slide preparation run without any issues or errors.Post intervention the instrument was left operating normally.Root cause is attributed to faulty tubing connection to diti.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 (b)(6) 2012.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.".

• Brand Name: BD PREPSTAIN¿ SLIDE PROCESSOR
• 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: 13359371
• Report Number: 1119779-2022-00119
• Device Sequence Number: 13871888
• Product Code: MKQ
• UDI-Device Identifier: 00382904904074
• UDI-Public: 00382904904074
• Combination Product (Y/N): N
• Initial Reporter State: NV
• Initial Reporter Country: US
• 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,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/04/2022

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: 490407
• Device Catalogue Number: 490407
• 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: 01/10/2022
• Supplement Date Received by Manufacturer: 04/03/2022
• Initial Report FDA Received Date: 01/26/2022
• Supplement Report FDA Received Date: 04/19/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/27/2014
• 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