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

Catalog Number	441386
Medical Device Problem Code	False Negative Result (1225)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/17/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Investigation summary: this complaint alleges that two bottles in drawer c of the bactec fx did not flag as positive.The patient had multiple bottles collected and subculture confirmed there was growth of streptococci.The customer confirmed that the patient was not impacted by the false results.A bd field service engineer (fse) went to the customer site and performed station qualification for drawer c, which confirmed that the instrument was working properly.The fse also reviewed past plots for this drawer to confirm there was no other bottles affected.There were no instrument issues present, the unit is working properly.This complaint is unconfirmed, and the root cause is unknown.No physical samples were received as part of this complaint; however, photos of bottle plots were provided 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 for manufacturing due to service repairs/pms.Service history review revealed there were no previous complaints for this issue.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.
Event or Problem Description
Report 2 of 2.It was reported after using bd bactec¿ fx, instrument bottom, packaged there was one false negative result from one patient.Subculture confirmed the growth of streptococci.No adverse impact was reported regarding the patient or user.
Additional Manufacturer Narrative
B3: date of event is unknown.The date received by manufacturer has been used for this field.E.1.Initial reporter facility name: (b)(6) hospital.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
Report 2 of 2.It was reported after using bd bactec¿ fx, instrument bottom, packaged there was one false negative result from one patient.Subculture confirmed the growth of streptococci.No adverse impact was reported regarding the patient or user.

• Brand Name: BD BACTEC¿ FX, INSTRUMENT BOTTOM, PACKAGED
• 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: 21378936
• Report Number: 1119779-2025-00064
• Device Sequence Number: 3849669
• Product Code: MDB
• UDI-Device Identifier: 00382904413866
• UDI-Public: (01)00382904413866(11)191001
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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,Foreign,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/25/2025

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: 441386
• 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: 01/17/2025
• Supplement Date Received by Manufacturer: 04/25/2025
• Initial Report FDA Received Date: 02/13/2025
• Supplement Report FDA Received Date: 05/06/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/01/2019
• 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