MAUDE Adverse Event Report: BECTON DICKINSON & CO. (SPARKS) BD BACTEC¿ FX40 INSTRUMENT; SYSTEM, BLOOD CULTURING

Catalog Number	442296
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/11/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
E.1.Initial reporter addr 1: (b)(6).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 while using bd bactec¿ fx40 instrument there was a mis association of one patient sample number.No adverse impact was reported regarding the patient or user.
Event or Problem Description
It was reported while using bd bactec¿ fx40 instrument there was a mis association of one patient sample number.No adverse impact was reported regarding the patient or user.The instrument did not generate any error and did not incorrectly associate a vial to the wrong patient; it was a customer induced error.
Additional Manufacturer Narrative
The following fields have been updated with corrected and/or additional information.B5.Description of event: it was reported while using bd bactec¿ fx40 instrument there was a mis association of one patient sample number.No adverse impact was reported regarding the patient or user.The instrument did not generate any error and did not incorrectly associate a vial to the wrong patient; it was a customer induced error.Investigation summary: the customer reported that there was a mis association of one patient sample number on their bactec fx40 instrument.Bd remote services contacted customer, it was noted that the instrument did not generate any error and did not incorrectly associate a vial to the wrong patient, this was a customer induced error.The customer contacted bd remote services since they were missing the knowledge to correct the error.The mistake was realized immediately.The bd application specialist team corrected the association.There was no impact on the patient.The root cause is workflow.This complaint is an unconfirmed failure of a bd product.Instrument is working properly.No parts were replaced as part of this complaint, and therefore no samples were returned, and no returned material investigation could occur, however, log files were collected and reviewed.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 from manufacturing due to service repairs/pms.Service history review for this instrument was completed and revealed one previous case (02685582) related to instrument performance / operation.Bd quality will continue to closely monitor for trends associated with this complaint.Review of risk management files confirms there are no new or modified risks associated with this failure mode.

• Brand Name: BD BACTEC¿ FX40 INSTRUMENT
• Common Device Name: SYSTEM, BLOOD CULTURING
• 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: 22994491
• Report Number: 1119779-2025-04956
• Device Sequence Number: 9620075
• Product Code: MDB
• UDI-Device Identifier: 00382904422967
• UDI-Public: (01)00382904422967
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• PMA/510(K) Number: K915796
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/13/2025

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: 442296
• 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: 08/11/2025
• Supplement Date Received by Manufacturer: 10/13/2025
• Initial Report FDA Received Date: 09/08/2025
• Supplement Report FDA Received Date: 10/16/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/07/2025
• 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