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

Catalog Number	490100
Medical Device Problem Code	Structural Problem (2506)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/15/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported while testing with bd prepstain slide processor, the centrifuge lid was not staying open.There was no health impact or consequences reported.
Additional Manufacturer Narrative
(b)(6) investigation summary: complaint reports lid failure on centrifuge associated with prepstain (catalog number 490100) serial number (b)(6).Complaint alleges centrifuge lid faulty hydraulic system.Customer advised no one was hurt or injured.Service replaced the centrifuge gas springs and post intervention the centrifuge was operating normally.Root cause attributed to faulty lid gas springs.This complaint is a confirmed failure of the instrument based on the customer investigation.Device history record review is not required because the part that allegedly failed is not tested as part of the manufacturing process but is shipped separately and tested during installation.Service history review was performed for the instrument 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 "centrifuge.".

• 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: jo doyka ; 7 loveton circle; sparks, MD 21152 ; 4103164000
• MDR Report Key: 19981876
• Report Number: 1119779-2024-00595
• Device Sequence Number: 15547399
• Product Code: MKQ
• UDI-Device Identifier: 00382904901004
• UDI-Public: (01)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,Foreign,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 07/26/2024

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 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: 07/15/2024
• Initial Report FDA Received Date: 08/14/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/23/2016
• 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