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

Catalog Number	441385
Medical Device Problem Code	Application Network Problem (2879)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/12/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A device evaluation is anticipated but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.
Event or Problem Description
It was reported while using bd bactec¿ fx top, accession numbers were incorrectly assigned.There was no report of adverse impact to patients or users.
Event or Problem Description
It was reported while using bd bactec¿ fx top, accession numbers were incorrectly assigned.There was no report of adverse impact to patients or users.
Additional Manufacturer Narrative
Investigation summary: this complaint alleges when the accession barcode is scanned on the bactec fx they are incorrect, however the sequence numbers are able to scan correctly.Bd service remoted into the instrument to review the issue.The customer provided "f79408" to be reviewed.Upon review it was observed that f79408 had two fx bottles associated, then f79408 had its association changed to h44489 with a pmic-106 sample and a maldi biotyper sample associated.The customer indicated that the accession barcode originally picked up four digits.Bd service advised the customer that the accession barcode comes from the facility lis and they should work with their facility lis vendor.Bd service confirmed epicenter working as expected.This complaint is unable to be confirmed, and the root cause is unknown.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 BACTEC¿ FX TOP
• 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: 23957598
• Report Number: 1119779-2025-05534
• Device Sequence Number: 21235266
• Product Code: MDB
• UDI-Device Identifier: 00382904413859
• UDI-Public: (01)00382904413859
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• 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): 01/09/2026

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: 441385
• 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: 12/12/2025
• Supplement Date Received by Manufacturer: 01/09/2026
• Initial Report FDA Received Date: 01/05/2026
• Supplement Report FDA Received Date: 01/12/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/27/2014
• 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