MAUDE Adverse Event Report: BECTON DICKINSON & CO. (SPARKS) INST PREPMATE FINAL ASSY UNIV 100-240V; PROCESSOR, CERVICAL CYTOLOGY SLIDE, AUTOMATED

Catalog Number	490104
Medical Device Problem Code	Structural Problem (2506)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/17/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The complaint alleges the prepmate (catalog number 490104, serial number (b)(6)) exhibit centrifuge lid struts failed.Faulty centrifuge lid struts replaced by field service engineer.The instrument tested and return.This is a confirmed complaint and root cause attribute to lid struts.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.The instrument was installed on 03/01/2009.Service history review was performed for the instrument, and no additional work orders were observed for the complaint failure mode reported.Samples were not received by quality for investigation and thus, returned material investigation could not occur.Review of risk management files confirm 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".
Event or Problem Description
It was reported while testing with the inst prepmate final assy univ 100-240v, the centrifuge lid springs no longer held the lid open.There was no health impact or consequences reported.

• Brand Name: INST PREPMATE FINAL ASSY UNIV 100-240V
• 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: 19508754
• Report Number: 1119779-2024-00497
• Device Sequence Number: 7498416
• Product Code: MKQ
• UDI-Device Identifier: 00382904901042
• UDI-Public: (01)00382904901042
• Combination Product (Y/N): N
• Initial Reporter Country: NZ
• 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): 05/31/2024

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: 490104
• 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: 05/17/2024
• Initial Report FDA Received Date: 06/11/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/22/2016
• 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