MAUDE Adverse Event Report: BECTON, DICKINSON & CO. (SPARKS) BD BACTEC¿ MGIT¿ 960 SUPPLEMENT KIT; SYSTEM, BLOOD CULTURING

Catalog Number	245124
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	07/02/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported before using the bd bactec¿ mgit¿ 960 supplement kit, fungal particles were observed in one (1) unopened supplement vial.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: mgit 960 supplement kit batch 4110719 is composed of mgit panta batch 4110716 and mgit 960 growth supplement batch 4110717.The batch history record review for mgit 960 supplement kit batch 4110719 was satisfactory.No quality notifications were generated during manufacturing and no other complaints for contamination have been taken on this kit batch.Mgit panta is 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 standard operating procedures (sop).Mgit 960 growth supplement is manufactured by rehydrating the media components with usp purified water and mixing 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 sop.Six mgit panta vials are then manually packaged with six mgit growth supplement vials to make a mgit 960 supplement kit (material 245124).The batch history record reviews for mgit panta batch 4110716 and mgit 960 growth supplement batch 4110717 were satisfactory, and no quality notifications were generated during manufacturing.Qc inspection was satisfactory at time of release.No other complaints have been taken on either batch.Retention samples of growth supplement 4110717 were available and were inspected as part of this investigation.The unopened vials did not show presence of contamination or foreign material inside the vial.Two vials of growth supplement 4110717 were incubated at 35c and 25c for 7 days.At 7 days, there was no observation of turbidity or any indication of the presence of a contaminant.Two photos were submitted to assist with the investigation of this complaint.One showed kit carton label of batch 4110719 exp 2026-10-17.A second photo is of a vial of growth supplement batch number 4110717 held up at an angle with its crimp cap still in place.This photo appears to show presence of foreign mater.There were no returned samples available for this investigation.This complaint can be confirmed for contamination; however, no further actions are indicated at this time.No complaint trends have been identified for this product.Bd will continue to monitor trends in complaints for contamination issues.
Event or Problem Description
It was reported before using the bd bactec¿ mgit¿ 960 supplement kit, fungal particles were observed in one (1) unopened supplement vial.There were no health impact or consequences reported.

• Brand Name: BD BACTEC¿ MGIT¿ 960 SUPPLEMENT KIT
• 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: 22636145
• Report Number: 1119779-2025-02035
• Device Sequence Number: 7989863
• Product Code: MDB
• UDI-Device Identifier: 00382902451242
• UDI-Public: (01)00382902451242(17)251017(10)4110719
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• 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): 10/21/2025

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: 10/17/2025
• Device Catalogue Number: 245124
• Device Lot Number: 4110719
• 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: 07/02/2025
• Supplement Date Received by Manufacturer: 10/21/2025
• Initial Report FDA Received Date: 07/28/2025
• Supplement Report FDA Received Date: 11/07/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/19/2024
• 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