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	08/04/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported while using the bd bactec¿ mgit¿ 960 sire kit, one (1) ethambutol patient culture tube had positive growth and appeared visibly turbid.In addition, a reconstituted ethambutol tube was inoculated without bacteria and visibly demonstrated turbid growth.A microscopic examination of a smear prepared from the tube revealed numerous cocci and other indistinct cellular forms.No clear acid-fast bacilli (afb) were observed.There were no health impact or consequences reported.This is report 3 of 3.
Additional Manufacturer Narrative
Investigation summary: introduction material #: 245123 batch #: 6110477 defect: contamination background mgit 960 sire supplement is manufactured by rehydrating the media components with usp purified water and mixed until a homogeneous solution is obtained.The solution is then sterile filtered and dispensed into vials; stoppers are manually placed in the vial opening; septum caps are manually placed on top of the stopper and then mechanically crimped per standard operating procedures (sop).Antibiotics mgit 960 streptomycin, mgit 960 isoniazid, mgit 960 rifampin and mgit 960 ethambutol are manufactured by rehydrating components in usp purified water and mixing into a homogenous solution.The solution is then sterile filtered, dispensed into vials and stoppered by machine.The vials are lyophilized and crimp caps are applied per sop.Eight mgit 960 sire supplement vials are then manually packaged with one vial of each antibiotic to make a mgit 960 sire supplement kit (material 245123).Batch history review the batch history record review was satisfactory.The release testing that is performed on this product does include physical attribute testing.The products are tested for physical attributes prior to release to ensure that they conform to product specifications.All physical attribute testing performed on this batch was satisfactory per bd internal procedures.Complaint history the complaint history was reviewed; a contamination trend has been identified.Sample testing photos were provided; however, review of retains and photos were not required as the complaint was confirmed through contamination trend.Conclusion a contamination trend, which includes this product, has been identified by bd.A corrective and preventive action (capa) has been opened to formally investigate the issue.Bd will continue to monitor and trend all contamination related complaints.

• 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 ; +1(410)316-4000
• MDR Report Key: 50325246
• Report Number: 1119779-2026-01633
• Device Sequence Number: 15946850
• Product Code: MJA
• UDI-Device Identifier: 00382902451235
• UDI-Public: (01)00382902451235(17)270801(10)6110477
• Combination Product (Y/N): N
• 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,Foreign,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/11/2026

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: 6110477
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: 09/04/2026
• Initial Report FDA Received Date: 08/19/2026
• Supplement Report FDA Received Date: 09/11/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/20/2026
• 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