MAUDE Adverse Event Report: BECTON, DICKINSON & CO. (SPARKS) BD BACTEC¿ MGIT¿ 320 INSTRUMENT; SYSTEM, BLOOD CULTURING

Catalog Number	441743
Medical Device Problem Code	False Negative Result (1225)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/09/2025
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 the bd bactec¿ mgit¿ 320 instrument, there were false negative results.There was no report of adverse patient impact.
Event or Problem Description
It was reported while using the bd bactec¿ mgit¿ 320 instrument, there were false negative results.There was no report of adverse patient impact.
Additional Manufacturer Narrative
Investigation summary: catalog # 441743, s/n (b)(6): this complaint was that the instrument was reporting false negative results.An fse went on site and after troubleshooting the problem replaced the smm.After this service, the instrument was running without errors and was returned to normal use.Due to the lack of an actionable trend on this failure mode, no corrective action is being taken at this time.The root cause of this complaint cannot be determined, however, because the smm replacement cleared the instrument for use, the complaint is confirmed.Review of the device history record for instrument s/n (b)(6) is not required because this complaint does not allege an early life failure or failure at installation and the instrument has changed configuration since release from manufacturing due to service repairs/pms.Service history review was performed for the instrument and no recent past additional instrument related work orders were observed for the complaint failure mode reported.Per service max, no samples or parts were expected to be returned for this complaint and thus, a returned sample analysis is not required.If samples are received at a later date, the complaint may be reopened and an investigation may occur.Bd quality will continue to closely monitor for trends associated with smm related complaints.No new risks or hazards, or changes to existing risks/hazards, were identified as a result of this complaint.

• Brand Name: BD BACTEC¿ MGIT¿ 320 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: 23828901
• Report Number: 1119779-2025-05504
• Device Sequence Number: 9268328
• Product Code: MDB
• UDI-Device Identifier: 00382904417437
• UDI-Public: (01)00382904417437
• Combination Product (Y/N): N
• Initial Reporter Country: BE
• PMA/510(K) Number: K974883
• 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): 01/14/2026

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: 441743
• 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: 12/09/2025
• Supplement Date Received by Manufacturer: 01/14/2026
• Initial Report FDA Received Date: 12/17/2025
• Supplement Report FDA Received Date: 01/16/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/25/2014
• 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