MAUDE Adverse Event Report: BECTON, DICKINSON & CO. (SPARKS) BD BACTEC¿ MGIT¿ 960 SIRE KIT; SUSCEPTIBILITY TEST POWDERS, ANTIMYCOBACTERIAL

Catalog Number	245123
Medical Device Problem Code	Incorrect, Inadequate or Imprecise Result or Readings (1535)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/27/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
B3.Date of event is unknown.The customer reports events occurred in 2025 and in 2026; however, no further information can be provided.The date received by manufacturer has been used for this field.D4.Medical device expiration date: unknown.H4.Device manufacture date: unknown.The information for the additional 510k is as follows: g4.Pma/510(k)#: k014123.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 sire kit, one (1) false resistant m.Tuberculosis patient result was obtained from a mgit instrument.No confirmatory testing was reported; however, the customer noted that no actual growth was observed.Repeat testing occurred and no adverse health impact was reported.This is report 27 of 42.

• Brand Name: BD BACTEC¿ MGIT¿ 960 SIRE KIT
• Common Device Name: SUSCEPTIBILITY TEST POWDERS, ANTIMYCOBACTERIAL
• 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: 24700587
• Report Number: 1119779-2026-00543
• Device Sequence Number: 16091356
• Product Code: MJA
• UDI-Device Identifier: 00382902451235
• UDI-Public: (01)00382902451235
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K003062
• 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): 05/26/2026

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: 245123
• Device Lot Number: UNKNOWN
• 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: 02/27/2026
• Supplement Date Received by Manufacturer: 05/06/2026
• Initial Report FDA Received Date: 03/26/2026
• Supplement Report FDA Received Date: 05/26/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): Yes
• 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