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

Catalog Number	442296
Medical Device Problem Code	Fire (1245)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/06/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported while using the bd bactec¿ fx40 instrument, the ups caught fire.There were no injuries or damage to structures.No adverse impact was reported regarding 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 while using the bd bactec¿ fx40 instrument, the ups caught fire.There were no injuries or damage to structures.No adverse impact was reported regarding the patient or user.
Additional Manufacturer Narrative
Investigation summary: the customer reported that the ups in use with a bactec fx40 instrument caught fire.A bd field service engineer (fse) was dispatched to investigate.The fse replaced the ups, checked ups and instrument operation and both were working properly, additionally cleaned the air filter and sanitized instrument, after which the issue was resolved.The root cause is unknown.This is a confirmed failure of a spare part of a bd product.The ups powervar model: abce802-22 has been designed and manufactured in such a way as to reduce, as far as possible, the risks of fire or explosion during normal use and in single fault condition.It has been evaluated to and meets the requirements of the following standards: ¿ ansi/ul 1778 (ul file: e122401).¿ csa 22.2 nos.107.3-14 (ul file: e122401).Physical samples were not received by quality for investigation and thus, returned material investigation could not occur.If physical samples are received at a later date, the complaint may be reopened.However, pictures were provided.There is no dhr review because this is a spare part.There is no service history because this investigation is for a spare part, not an instrument.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: 22631276
• Report Number: 1119779-2025-02030
• Device Sequence Number: 7978329
• Product Code: MDB
• UDI-Device Identifier: 00382904422967
• UDI-Public: (01)00382904422967(11)200309
• 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,Foreign,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/01/2025

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: 06/06/2025
• Supplement Date Received by Manufacturer: 08/01/2025
• Initial Report FDA Received Date: 07/28/2025
• Supplement Report FDA Received Date: 08/01/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/09/2020
• 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