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

Model Number	490407
Medical Device Problem Code	Unintended Movement (3026)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/31/2022
Type of Reportable Event	Malfunction
Event or Problem 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.".
Additional 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
• Common Device Name: 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
• Report Number: 1119779-2022-00314
• Device Sequence Number: 4673889
• Product Code: MKQ
• UDI-Device Identifier: 00382904904074
• UDI-Public: 00382904904074
• Combination Product (Y/N): N
• Initial Reporter Country: HK
• PMA/510(K) Number: P970018
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 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
• Operator of Device: Other
• Device Model Number: 490407
• Device Catalogue Number: 490407
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/31/2022
• Initial Report FDA Received Date: 02/28/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 12/22/2016
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown