MAUDE Adverse Event Report: BECTON, DICKINSON & CO. (SPARKS) BD BACTEC¿ MGIT¿ MYCOBACTERIA GROWTH INDICATOR TUBES; SYSTEM, BLOOD CULTURING

Catalog Number	245122
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	03/13/2026
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 bd bactec¿ mgit¿ mycobacteria growth indicator tubes, one (1) negative patient result was obtained from a mgit 960 instrument.Upon performing parallel testing which included culturing using lowenstein¿jensen media and tb-ict, a positive result was obtained.There were no health impact or consequences reported.
Additional Manufacturer Narrative
Investigation summary: material 245122 is manufactured by rehydrating the media components with usp purified water and thoroughly mixing until a homogeneous solution is obtained.The tubes are filled, capped, torqued and then labeled by machine per standard operating procedure (sop).The tubes are terminally autoclaved in an air over pressure (aop) autoclave, per manufacturing instructions, using a validated cycle.Post autoclaving, tubes are packaged into final shipping configurations.The batch history record review for batch 5099192 was satisfactory per internal procedures.Formulation, torquing, and filling processes were within specifications.In process checks were performed at the designated intervals.Checks for fill volume were complete and within specifications per procedures.Those checks also confirmed that the caps were tightened to the validated specifications.Qc inspection and testing were satisfactory at time of release.The complaint history was reviewed, no trends were identified for performance issues.Retention samples were available for inspection and were performance tested for growth and antibiotic susceptibility per the bd standard performance protocol for material 245122.All organisms tested for growth, as listed in the certificate of analysis, had detectible growth in the instrument within the expected incubation time.Additionally, antibiotic susceptibility testing was satisfactory with detectible growth controls and expected susceptibility results for the organisms against the drugs tested.Four photos were provided for this investigation.Two photos show a single tube from batch 5099192; the tubes can be seen to have growth in them.One photo shows a performance graph.One photo shows a label on the bactec equipment.Conclusions on performance cannot be drawn from photos provided.There are no physical returns received to assist with the investigation of this complaint.This complaint cannot be confirmed based on the inspection and testing performed on retention samples which yielded satisfactory results.No complaint trends for this defect have been identified; no actions are indicated at this time.Bd will continue to trend complaints for defects.
Event or Problem Description
It was reported while using bd bactec¿ mgit¿ mycobacteria growth indicator tubes, one (1) negative patient result was obtained from a mgit 960 instrument.Upon performing parallel testing which included culturing using lowenstein¿jensen media and tb-ict, a positive result was obtained.There were no health impact or consequences reported.

• Brand Name: BD BACTEC¿ MGIT¿ MYCOBACTERIA GROWTH INDICATOR TUBES
• 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: 24801203
• Report Number: 1119779-2026-00614
• Device Sequence Number: 10678724
• Product Code: MDB
• UDI-Device Identifier: 00382902451228
• UDI-Public: (01)00382902451228(17)261004(10)5099192
• 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): 04/30/2026

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 Expiration Date: 10/04/2026
• Device Catalogue Number: 245122
• Device Lot Number: 5099192
• 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: 03/15/2026
• Supplement Date Received by Manufacturer: 04/30/2026
• Initial Report FDA Received Date: 04/07/2026
• Supplement Report FDA Received Date: 05/26/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/09/2025
• 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