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

Model Number 490407

Device Problem Unintended Movement (3026)

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

Event Date 01/31/2022

Event Type  malfunction  

Event Description

It was reported that the bd prepstain¿ slide processor's centrifuge lid would not close properly.There was no adverse user or patient impact.The following information was provided by the initial reporter: "centrifuge lid not closing properly" "nobody was hurt due to this issue.Yes, the centrifuge now operating normally.".

Manufacturer Narrative

Medical device expiration date: na.Investigation summary: bd quality has reviewed the complaint, service activities, and adverse event questions.The results of this evaluation have not identified any new hazards, new risks, or specific trends.Complaints received for this device and reported condition will continue to be tracked and trended.Additional investigation will be performed if an actionable level is reached.

• 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 ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 13620831
• MDR Text Key: 288667126
• Report Number: 1119779-2022-00314
• Device Sequence Number: 1
• Product Code: MKQ
• UDI-Device Identifier: 00382904904074
• UDI-Public: 00382904904074
• Combination Product (y/n): N
• Reporter Country Code: HK
• 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: 02/25/2022

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 Model Number: 490407
• Device Catalogue Number: 490407
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/31/2022
• Initial Date FDA Received: 02/28/2022
• 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