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

Catalog Number	441385
Medical Device Problem Code	Incorrect, Inadequate or Imprecise Result or Readings (1535)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/23/2024
Type of Reportable Event	Malfunction
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 bd bactec fx top, the incorrect sequence number was captured from a scanned bactec bottle.This occurred with two (2) bottles.No adverse impact was reported regarding the patient or user.
Additional Manufacturer Narrative
Investigation summary: a failure was reported on a bactec fx top instrument.The customer reported that a wrong sequence number was captured from the scanned bottle.Log files were collected for analysis.From the log files, it was determined to not be an instrumentation related issue.The problem appeared to be a workflow related issue.Bd remote services assisted the customer with vial dissociation and association workflow steps.The instrument is working properly.The root cause is unknown.This complaint is an unconfirmed failure of a bd product.Physical samples were not received by quality for investigation however, log files were received and reviewed.If physical samples are received at a later date, the complaint may be reopened.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 no previous complaints 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.
Event or Problem Description
It was reported that while using bd bactec fx top, the incorrect sequence number was captured from a scanned bactec bottle.This occurred with two (2) bottles.No adverse impact was reported regarding the patient or user.

• 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: 20651491
• Report Number: 1119779-2024-00820
• Device Sequence Number: 6681879
• Product Code: MDB
• UDI-Device Identifier: 00382904413859
• UDI-Public: (01)00382904413859(11)200108
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/25/2025

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: 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: 10/24/2024
• Supplement Date Received by Manufacturer: 03/25/2025
• Initial Report FDA Received Date: 11/11/2024
• Supplement Report FDA Received Date: 03/31/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/08/2020
• 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