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	05/03/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that wile using bd prepstain¿ during staining process there was a probe touching one of the slides and cross-contamination occurred.Sample was re stained and no injuries or treatment change affected patient.The following information was provided by the initial reporter: tripath us ii - tablet contamination during the staining process, the laboratory physician identified only 1 case of cross-contaminated samples when viewed under the microscope.After investigation by fse, it was found that there was a probe touching one of the slides.Afterwards, the laboratory physician re-prepared the patient sample and re-stained it, which did not affect the test results or the treatment of the patient.
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.
Additional Manufacturer Narrative
H6.Investigation summary: complaint reports contamination on prepstain (catalog number 490100) serial number (b)(6).Complaint alleges during the staining process the laboratory technician identified cross-contaminated samples when viewed under the microscope.Customer stated no erroneous results reported.Service adjusted the parameters and position of the quad bundles.Laboratory technician re-prepared the samples and re-stained, post staining process the samples slides showed no contamination.Root cause attributed to quad bundles touching slides.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) 2019.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 "contamination / foreign matter.".
Event or Problem Description
It was reported that wile using bd prepstain¿ during staining process there was a probe touching one of the slides and cross-contamination occurred.Sample was re stained and no injuries or treatment change affected patient.The following information was provided by the initial reporter: tripath us ii - tablet contamination.During the staining process, the laboratory physician identified only 1 case of cross-contaminated samples when viewed under the microscope.After investigation by fse, it was found that there was a probe touching one of the slides.Afterwards, the laboratory physician re-prepared the patient sample and re-stained it, which did not affect the test results or the treatment of the patient.

• 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 ; 5859 farinon drive; san antonio, TX 78249 ; 8448235433
• MDR Report Key: 17039541
• Report Number: 1119779-2023-00602
• Device Sequence Number: 6412995
• Product Code: MKQ
• UDI-Device Identifier: 00382904901004
• UDI-Public: 00382904901004
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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): 06/08/2023

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 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: 05/03/2023
• Supplement Date Received by Manufacturer: 06/08/2023
• Initial Report FDA Received Date: 06/01/2023
• Supplement Report FDA Received Date: 06/13/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/13/2019
• 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