MAUDE Adverse Event Report: BECTON DICKINSON & CO. (SPARKS) BD COR¿ PX INSTRUMENT; NUCLEIC ACID SAMPLE PREPARATION INSTRUMENT IVD

Catalog Number	443988
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/06/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that while using the bd cor¿ px instrument, the robot arm continued to move and function while the door was opened.There was no report of adverse impact to the patient or user.
Additional Manufacturer Narrative
A device evaluation and/or device history review is anticipated but is not complete.Upon completion, a supplemental report will be filed.
Event or Problem Description
It was reported that while using the bd cor¿ px instrument, the robot arm continued to move and function while the door was opened.There was no report of adverse impact to the patient or user.
Additional Manufacturer Narrative
This complaint alleges the bd cor px was being run with the doors open.This issue was confirmed through video files provided for troubleshooting on case (b)(4).Bd service followed up with the customer.The customer was using an off-label method of bypassing the instrument safety door lock mechanism of running the px with the doors open.The customer was told about the safety concern this presents for the employees running the instrument.The customer has agreed they will no longer run the instrument with the doors open.No further troubleshooting was needed on the instrument.This complaint is unable to be confirmed as an instrument failure, and the root cause was a customer workflow issue.No samples were expected to be received as part of this complaint, and therefore no samples were available for returned material investigation.Dhr review is not required for this complaint as this complaint does not allege an early life failure or failure at installation and the configuration has changed since release for manufacturing due to service repairs/pms.Service history review for this instrument was completed and revealed no previous complaints related to this failure mode.Bd quality will continue to monitor for trends associated with the failure mode described in this complaint.Review of risk management files confirms there are no new or modified risks associated with this failure mode.

• Brand Name: BD COR¿ PX INSTRUMENT
• Common Device Name: NUCLEIC ACID SAMPLE PREPARATION INSTRUMENT IVD
• 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: matt j. connor ; 7 loveton circle; sparks, MD 21152 ; 4103164000
• MDR Report Key: 23467063
• Report Number: 1119779-2025-05223
• Device Sequence Number: 21315074
• Product Code: MAQ
• UDI-Device Identifier: 00382904439880
• UDI-Public: (01)00382904439880
• Combination Product (Y/N): N
• Initial Reporter Country: SW
• PMA/510(K) Number: P160037
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/26/2026

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 Catalogue Number: 443988
• 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: 10/06/2025
• Supplement Date Received by Manufacturer: 01/26/2026
• Initial Report FDA Received Date: 11/04/2025
• Supplement Report FDA Received Date: 01/27/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/04/2021
• 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