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

Catalog Number 490100

Device Problem Structural Problem (2506)

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

Event Date 10/05/2023

Event Type  malfunction  

Manufacturer Narrative

H3.A device evaluation is anticipated but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.

Event Description

It was reported that the centrifuge lid of the bd prepstain¿ would not stay up.There was no report of impact to patient or user.The following information was provided by the initial reporter: faulty hydraulic system in our centrifuge lid.

Manufacturer Narrative

H.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.Customer replaced 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 customer investigation.Device history record review revealed no abnormalities during build and test of this unit prior to shipping, as it is related to the failure mode reported.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.".

Event Description

It was reported that the centrifuge lid of the bd prepstain¿ would not stay up.There was no report of impact to patient or user.The following information was provided by the initial reporter: faulty hydraulic system in our centrifuge lid.

• 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: jennifer suh ; 9450 south state street; sandy, UT 84070 ; 8448235433
• MDR Report Key: 18030566
• MDR Text Key: 327258636
• Report Number: 1119779-2023-01192
• Device Sequence Number: 1
• Product Code: MKQ
• UDI-Device Identifier: 00382904901004
• UDI-Public: (01)00382904901004
• Combination Product (y/n): N
• Reporter Country Code: SF
• 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: 05/13/2024

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
• Device Operator: Other
• Device Catalogue Number: 490100
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/05/2023
• Initial Date FDA Received: 10/30/2023
• Supplement Dates Manufacturer Received: 05/13/2024
• Supplement Dates FDA Received: 05/13/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/22/2016
• 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