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

Model Number 490100

Device Problem Structural Problem (2506)

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

Event Date 04/28/2023

Event Type  malfunction  

Event Description

It was reported that while using the bd prepstain¿ that there was centrifuge lid issues.The following information was provided by the initial reporter: centrifuge lid issues.

Manufacturer Narrative

E.6 initial reporter e-mail: (b)(6).H.3.A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.

Manufacturer Narrative

Investigation summary: complaint reports lid failure on centrifuge associated with prepstain (catalog number 490100) serial number (b)(6).Complaint alleges centrifuge hydraulic rod failure, no support for the lid to stay open.Customer advised no one was hurt or injured.Service replaced the centrifuge and post intervention the centrifuges were operating normally.Root cause attributed to faulty hydraulic rods.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.

Event Description

It was reported that while using the bd prepstain¿ that there was centrifuge lid issues.The following information was provided by the initial reporter: centrifuge lid issues.

• Brand Name: BD PREPSTAIN¿
• 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: 16904584
• MDR Text Key: 315359474
• Report Number: 1119779-2023-00540
• Device Sequence Number: 1
• Product Code: MKQ
• UDI-Device Identifier: 00382904901004
• UDI-Public: 00382904901004
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P970018
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility,Company Representative
• 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: 05/10/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: 490100
• Device Catalogue Number: 490100
• 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: 03/27/2014
• 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