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

Model Number 490410

Device Problem Structural Problem (2506)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 05/31/2023

Event Type  malfunction  

Manufacturer Narrative

D.4.Medical device expiration date: unknown.E.1.Initial reporter phone #: (b)(6).H.3.A device evaluation and/or device history review is anticipated but is not complete.Upon completion, a supplemental report will be filed.

Event Description

It was reported while using bd prepstain slide processor the centrifuge dampers are worn and the instrument lid does not stay open.There was no patient impact nor erroneous results reported.The following information was provided by the initial reporter: "the reported failure mode reports that the dampers are worn and the instrument lid does not stay open.".

Manufacturer Narrative

H.6.Investigation summary: complaint reports lid failure on centrifuge associated with prepmate (catalog number 490410) serial number (b)(6).Complaint alleges centrifuge lid gas springs failure, no support for the lid to stay open.Customer advised no one was hurt or injured.Service replaced the gas springs on the centrifuge 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 service investigation.Dhr 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.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.".

Event Description

It was reported while using bd prepstain slide processor the centrifuge dampers are worn and the instrument lid does not stay open.There was no patient impact nor erroneous results reported.The following information was provided by the initial reporter: "the reported failure mode reports that the dampers are worn and the instrument lid does not stay open.".

• Brand Name: BD PREPSTAIN SLIDE PROCESSOR
• Type of Device: 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: 17234770
• MDR Text Key: 318377670
• Report Number: 1119779-2023-00725
• Device Sequence Number: 1
• Product Code: MKQ
• UDI-Device Identifier: 00382904904104
• UDI-Public: 00382904904104
• Combination Product (y/n): N
• Reporter Country Code: BR
• PMA/PMN Number: P970018
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 08/09/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/29/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: 490410
• Device Catalogue Number: 490410
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/09/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/26/2016
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1