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	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.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¿ mycobacteria growth indicator tubes, one (1) false resistant m.Tuberculosis patient result was obtained from a mgit instrument.The customer is unable to provide the number of affected patient samples or tubes used with a specific product lot.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 55 of 61.
Event or Problem Description
It was reported while using the bd bactec¿ mgit¿ mycobacteria growth indicator tubes, one (1) false resistant m.Tuberculosis patient result was obtained from a mgit instrument.The customer is unable to provide the number of affected patient samples or tubes used with a specific product lot.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 55 of 61.
Additional Manufacturer Narrative
Investigation summary: material #: 245122 batch #: unknown defect: no/false reaction background 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.Batch history review no batch number was provided for this complaint investigation.Therefore, trending was done on the appropriate databases for bactec mgit 7ml (material 245122) and no quality notification trends have been identified for this material in the last 12 months.Complaint history the complaint history was reviewed for material 245122 and there are no trends for performance issues in the last 12 months.Return material analysis no physical return samples or photos were provided for this investigation.Investigation as no batch information was provided, retention analysis cannot be performed.All batches are tested prior to release and results reported on the certificate of analysis which can be obtained at www.Bd.Com/regdocs.Tube bactec mgit 7 ml is stability tested biennially for biological performance to ensure satisfactory performance throughout shelf life with the organisms that are reported on the certificate of analysis.Conclusion as no batch number was provided, this complaint cannot be confirmed.No complaint trends for this defect have been identified; no actions are indicated at this time.Bd will continue to trend complaints for defects.

• 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: 24700641
• Report Number: 1119779-2026-00572
• Device Sequence Number: 10463288
• Product Code: MDB
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• 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,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/30/2026

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 Catalogue Number: 245122
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/27/2026
• Supplement Date Received by Manufacturer: 06/23/2026
• Initial Report FDA Received Date: 03/26/2026
• Supplement Report FDA Received Date: 06/30/2026
• 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