MAUDE Adverse Event Report: BECTON, DICKINSON & CO. (Sparks) BD BACTEC¿ MGIT¿ 960 PZA Kit; SUSCEPTIBILITY TEST POWDERS, ANTIMYCOBACTERIAL

Catalog Number	245128
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	08/14/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported while using the bd bactec¿ mgit¿ 960 pza kit, one (1) false resistant patient sample to pza was obtained.Whole genome sequencing was performed and showed the absence of a pza resistance mutation.There were no health impact or consequences reported.This is report 10 of 37.
Additional Manufacturer Narrative
B3.Date of event is unknown.The date received by manufacturer has been used for this field.Investigation summary: introduction material #: 245128 batch #: 5336427 defect: customer reports false resistant pza results.Background bactec mgit 960 pza is manufactured by rehydrating components in usp purified water and mixed into a homogenous solution.The solution is then sterile filtered, dispensed into vials and stoppered.The vials are lyophilized, and crimp caps are applied per standard operating procedures (sop).Bactec mgit 960 pza supplement is manufactured by rehydrating the media components with usp purified water and mixed 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.Two bactec mgit 960 pza vials are then manually packaged with six bactec mgit 960 pza supplement vials to complete a bactec mgit 960 pza kit (material 245128).Batch history review the batch history record review for batch 5336427 was satisfactory and no quality notifications were generated during manufacturing and inspection.The release testing that is performed on this product does include physical attribute testing.The products are tested for physical attributes prior to release to ensure that they conform to product specifications.All physical attribute testing performed on this batch was satisfactory per bd internal procedures.Returned material analysis returned material analysis could not be performed as there are no returned materials available.Complaint history the complaint history was reviewed; a trend in performance complaints has been identified for 245128 mgit pza kit.Investigation there are no photos available to assist with this investigation.Retention samples were tested per the standard performance procedure which is also described in the ifu (instructions for use, available on bd.Com/e-labeling).Retention sample testing conducted for investigation was unable to replicate the false resistance defect.Conclusion although we were unable to replicate the failure, this complaint is confirmed.A trend in performance complaints was identified for 245128 mgit pza kit.Bd initiated a capa (corrective and preventative action) to formally investigate the performance issue.As part of the capa implementation, pza was cleared to return to market with regulatory consensus by limited claims for the day 3-5 inoculum preparation method only and shortened shelf life.Kit batches were released beginning in november 2025.Long term strategy is to bring the product back to market with reduced ph, all three inoculation methods and 12-month shelf life.This long term strategy will support the goal of returning to historical complaints levels for false resistance.

• Brand Name: BD BACTEC¿ MGIT¿ 960 PZA Kit
• Common Device Name: SUSCEPTIBILITY TEST POWDERS, ANTIMYCOBACTERIAL
• 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 ; +1(410)316-4000
• MDR Report Key: 50588152
• Report Number: 1119779-2026-01802
• Device Sequence Number: 18564680
• Product Code: MJA
• UDI-Device Identifier: 00382902451280
• UDI-Public: (01)00382902451280(17)261106(10)5336427
• Combination Product (Y/N): N
• Initial Reporter Country: BE
• PMA/510(K) Number: K021582
• 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
• Report Date (Section B): 09/03/2026

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: 245128
• Device Lot Number: 5336427
• 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: Not provided
• Initial Report FDA Received Date: 09/03/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/02/2025
• 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