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	09/16/2025
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 bd bactec¿ mgit¿ mycobacteria growth indicator tubes, one false negative result was obtained; the immunochromatographic and bacilloscopic test confirmed positive result.There was no health impact or consequence reported.
Event or Problem Description
It was reported while using bd bactec¿ mgit¿ mycobacteria growth indicator tubes, one false negative result was obtained; the immunochromatographic and bacilloscopic test confirmed positive result.There was no health impact or consequence 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 4060549 was satisfactory and no quality notifications were generated during manufacturing and inspection.Formulation, filling, and autoclaving processes were within specifications.Qc inspection and testing were satisfactory at time of release.The complaint history was reviewed and there are no other complaints for performance on this batch.Retention samples of batch 4060549 were not available for this investigation.Four (4) photos were provided for this investigation: two photos of a micrograph.One photo of a test sheet showing results.One photo from the bd epicenter application.Conclusions on performance defects cannot be drawn from photos received from customers.No return samples were received to assist with the investigation.This complaint cannot be confirmed for performance issues.It is noted that batch 4060549 expired on 24-aug-2025, and this complaint was taken on 19-sep-2025.Bd makes no claims on expired products.No trend was identified for this product; no actions are indicated at this time.Bd will continue to trend complaints for this defect.

• 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: 23293336
• Report Number: 1119779-2025-05126
• Device Sequence Number: 9926093
• Product Code: MDB
• UDI-Device Identifier: 30382902451229
• UDI-Public: (01)30382902451229(17)250824(10)4060549
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• 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,Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/02/2025

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: 08/24/2025
• Device Catalogue Number: 245122
• Device Lot Number: 4060549
• 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: 09/19/2025
• Supplement Date Received by Manufacturer: 12/02/2025
• Initial Report FDA Received Date: 10/15/2025
• Supplement Report FDA Received Date: 12/15/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/29/2024
• 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