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

Catalog Number	245115
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	04/02/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
E1.Facility name: (b)(6).Investigation summary: material 245115 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 bd mgit pza testing system consists of mgit pza 7ml tubes (material 245115) and the mgit pza drug kit (material 245128).The mgit pza drug kit consists of lyophilized pza drug and liquid pza supplement components.The pza drug, pza supplement and pza 7ml tubes are used together to perform pza testing in the bd bactec mgit instruments.A complaint trend for performance was identified involving 245115 and 245128 mgit pza kit batches.Bd has initiated a capa (corrective and preventative action) to formally investigate the performance issue.The investigation has ruled out mgit pza 7ml tubes (material 245115) as the cause of increased, intermittent false resistance results observed.The batch history record review is satisfactory for the incident lot.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 complaint investigations have not replicated the reported defect.Because the mgit pza 7ml tubes were ruled out by the capa investigation and retention sample testing has not replicated the false resistance, this complaint cannot be confirmed.Bd will continue to trend complaints for performance.This mdr is being submitted as part of a retrospective review of records dating april 2023-2025, under capa 11910483.
Event or Problem Description
It was reported while using bd bactec¿ mgit¿ 960 pza medium, there was a false resistant result.There was no report of patient impact.

• Brand Name: BD BACTEC¿ MGIT¿ 960 PZA MEDIUM
• 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 ; 4103164000
• MDR Report Key: 22960997
• Report Number: 1119779-2025-04903
• Device Sequence Number: 8260296
• Product Code: MJA
• UDI-Device Identifier: 30382902451151
• UDI-Public: (01)30382902451151(11)230816(17)250215(10)3228567
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• 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,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 07/31/2025

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: 02/15/2025
• Device Catalogue Number: 245115
• Device Lot Number: 3228567
• 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: 04/02/2024
• Initial Report FDA Received Date: 09/04/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/16/2023
• 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