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

Catalog Number	445870
Medical Device Problem Code	Incorrect Measurement (1383)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/03/2025
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¿ 960 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¿ 960 instrument, there were false negative results.There was no report of adverse patient impact.
Additional Manufacturer Narrative
Investigation summary: catalog # 445870, s/n (b)(6): it was reported that there were possible conflicting results/false negative from the instrument.An fse was dispatched to the site and inspected the instrument.After noting dirt on the detectors, the fse cleaned the detectors in all three drawers.It was then reported that the instrument was functioning according to specifications.The case was closed.The root cause cannot be determined.This complaint is not being confirmed as no instrument malfunction was identified.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.No samples or parts were expected to be returned for this complaint and thus, a returned sample analysis is not required.Service history review was performed for the instrument and no recent additional work orders were observed for the complaint failure mode reported.Bd quality will continue to closely monitor for trends associated with results related complaints.No new risks or hazards, or changes to existing risks/hazards, were identified as a result of this complaint.

• Brand Name: BACTEC MGIT
• 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: 23828131
• Report Number: 1119779-2025-05500
• Device Sequence Number: 12029013
• Product Code: MDB
• UDI-Device Identifier: 00382904458706
• UDI-Public: (01)00382904458706
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• 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): 01/06/2026

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: 445870
• 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: 12/03/2025
• Supplement Date Received by Manufacturer: 01/06/2026
• Initial Report FDA Received Date: 12/17/2025
• Supplement Report FDA Received Date: 01/07/2026
• 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