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

Catalog Number	441386
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/20/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported while using bd bactec¿ fx, instrument bottom, packaged one bactec bottle broke inside the instrument, causing blood/sample to leak out.No adverse impact was reported regarding the patient or user.
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.
Additional Manufacturer Narrative
Investigation summary: this complaint alleges that a bottle broke in drawer d of the bactec fx.The customer was concerned about the blood leakage in the instrument that they cannot reach to clean up.The customer also noted that there was no harm or injury due to the broken bottle.A bd field service engineer (fse) went to the customer site and cleaned drawer d to remove the blood that leaked out of the broken bottle.The fse also removed racks and applied nyogel as a preventative measure.The instrument was verified to be operating to specification.This complaint is unconfirmed due to no instrument failure being observed, and the root cause is unknown.Samples were not received by quality for investigation and thus, returned material investigation could not occur.If 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 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
It was reported while using bd bactec¿ fx, instrument bottom, packaged one bactec bottle broke inside the instrument, causing blood/sample to leak out.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: 21406504
• Report Number: 1119779-2025-00085
• Device Sequence Number: 8523733
• Product Code: MDB
• UDI-Device Identifier: 00382904413866
• UDI-Public: (01)00382904413866(11)150901
• Combination Product (Y/N): N
• Initial Reporter State: DC
• 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): 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: 01/20/2025
• Supplement Date Received by Manufacturer: 04/25/2025
• Initial Report FDA Received Date: 02/18/2025
• Supplement Report FDA Received Date: 05/06/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/01/2015
• 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