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.

• 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
• Report Date: 10/26/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/30/2023
• 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
• Date Manufacturer Received: 10/05/2023
• 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