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

Catalog Number	441385
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/11/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported while using the bd bactec¿ fx top, a cracked bottle was used in the instrument which led to instrument contamination with patient sample.There was no report of impact to patient or user.
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 the bd bactec¿ fx top, a cracked bottle was used in the instrument which led to instrument contamination with patient sample.There was no report of impact to patient or user.
Additional Manufacturer Narrative
Investigation summary: the customer reported they had accidentally put in a cracked bottle in drawer b station k 10 in their bactec fx top instrument.The blood and media were leaking onto the instrument, customer noted they cleaned up the station.A bd field service engineer (fse) was dispatched to aid.The fse removed the rack for customer to clean up spilled blood media, applied nyogel and installed shorting pin, and the cleaning was completed.Since there were no instrumentation issues reported, and the unit was working properly this is an unconfirmed failure of a bd product.No samples were expected to be received as part of this complaint, and therefore no samples were returned, and no returned material investigation could occur.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 for this instrument was reviewed 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.A review of this failure has confirmed the event is not likely to contribute to a serious injury or death with the rationale below.This report will be the final submitted for this failure.Bd has reviewed 2 years of data associated with the failure and determined that the failure has not contributed to a death or serious injury.Leakage of fluid or sample contained within the instrument is unlikely to lead to a serious injury or death.This particular event is likely to be associated with a short-term interruption requiring the user to block the station and request cleaning of the device.

• 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: 21793000
• Report Number: 1119779-2025-00250
• Device Sequence Number: 15601536
• Product Code: MDB
• UDI-Device Identifier: 00382904413859
• UDI-Public: (01)00382904413859(11)140327
• Combination Product (Y/N): N
• Initial Reporter State: MD
• 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): 06/18/2025

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: 03/12/2025
• Supplement Date Received by Manufacturer: 06/18/2025
• Initial Report FDA Received Date: 04/07/2025
• Supplement Report FDA Received Date: 07/14/2025
• 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