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	Device Markings/Labelling Problem (2911)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/22/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported before using bd bactec¿ mgit¿ mycobacteria growth indicator tubes, the customer observed the outside label of one (1) repackaged carton kit contained an expiration date issue.Included in the repackaged carton kit were supplement kits (expiration date 03-oct-2025) along with mgit mycobacteria growth indicator tubes (expiration date 31-aug-2025).The outside label of the repackaged carton kit indicated the expiration date was 03-oct-2025 and not the earlier date of 31-aug-2025.There were no health impact or consequences reported.
Additional Manufacturer Narrative
A device evaluation is anticipated but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.
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 4066760 was satisfactory and no quality notifications were generated during manufacturing or inspection.Formulation, filling, and autoclaving processes were within specifications.In process checks are performed during manufacturing at designated intervals per procedures.Qc inspection and testing were satisfactory at time of release.The labeling process for material 245122 includes label control and reconciliation where the information of the labels is verified.The label control and reconciliation for batch 4066760 shows there were no issues with labels after manufacturing.This review does not support the incidence of incorrect expiry described by the customer.The complaint history was reviewed, and no other complaints have been taken on this batch for labeling error in regards to expiration date.Retention samples were not needed for this investigation as photo evidence was provided.There are nine photos provided to assist with this investigation; one photo shows a box with a non-bd label for batch 4088992 with an expiry of 03-oct-2025.Two photos show mgit 960 supplement kits of batch 4088992 expiring in 03-oct-2025.One photo shows one box of mgit 7ml tubes of batch 4066760 expiring 31-aug-2025.Two photos show a box with non-bd labels of lot 4088992 and expiring 03-oct-2025.One photo shows one box of mgit 7ml tubes of batch 4066760 expiring 31-aug-2025.One photo shows two vials, batch 4088989 (mgit supplement expiring 04-oct-2025) and 4088898 (mgit panta expiring 03-oct-2025).One photo shows a single tube of mgit 7ml, batch 4066760 expiring 31-aug-2025.There were no returns available to assist with this investigation.This complaint cannot be confirmed for labelling error.The bd labels presented in the photos appear to have the correct expiration dates.No complaint trends 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 before using bd bactec¿ mgit¿ mycobacteria growth indicator tubes, the customer observed the outside label of one (1) repackaged carton kit contained an expiration date issue.Included in the repackaged carton kit were supplement kits (expiration date 03-oct-2025) along with mgit mycobacteria growth indicator tubes (expiration date 31-aug-2025).The outside label of the repackaged carton kit indicated the expiration date was 03-oct-2025 and not the earlier date of 31-aug-2025.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: 23084473
• Report Number: 1119779-2025-04990
• Device Sequence Number: 11923639
• Product Code: MDB
• UDI-Device Identifier: 30382902451229
• UDI-Public: (01)30382902451229(17)250831(10)4066760
• 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): 11/13/2025

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: 08/31/2025
• Device Catalogue Number: 245122
• Device Lot Number: 4066760
• 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: 08/22/2025
• Supplement Date Received by Manufacturer: 11/13/2025
• Initial Report FDA Received Date: 09/18/2025
• Supplement Report FDA Received Date: 11/14/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/06/2024
• 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