MAUDE Adverse Event Report: BECTON DICKINSON & CO. (SPARKS) BD BBL¿ MGIT¿ MYCOBACTERIA GROWTH INDICATOR TUBES; SYSTEM, BLOOD CULTURING

Catalog Number	245113
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	05/20/2024
Type of Reportable Event	Malfunction
Event or Problem Description
Report 4 of 5.It was reported when using the bd bbl¿ mgit¿ mycobacteria growth indicator tubes, contamination occurred with m.Tuberculosis complex in one (1) patient sample per identification from quest.No information could be provided by the customer regarding patient impact.
Additional Manufacturer Narrative
The information for the additional phone # is as follows: e.1.Initial reporter phone #:(b)(6).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 245113 is manufactured by rehydrating the media components with usp purified water, and thoroughly mixing until a homogeneous solution is obtained.The media is dispensed into bottles; caps are applied manually then torqued by machine per a standard operating procedure (sop).The bottles are then labeled and terminally autoclaved in an air over pressure (aop) autoclave, per manufacturing instructions, using a validated cycle.Post autoclaving, bottles are packaged into final shipping configurations.The batch history record review for batch 3333194 was satisfactory and no quality notifications were generated during manufacturing and inspection.Formulation, filling, torquing, and autoclaving processes were within specifications.In process checks were performed at the designated intervals.Those checks confirmed that the caps were tightened to the validated specifications per internal procedure.Qc inspection and testing were satisfactory at time of release.As part of the release criteria for this product, the bhr was reviewed to confirm the following: the total elapsed time between end of formulation and start of the autoclave cycle was within the specified limits.All autoclave parameters conformed to the validated cycle parameters for this product.The minimum f0 for this product was met.The complaint history was reviewed, and there are no other complaints taken on batch 3333194.Retention samples from batch 3333194 were not available for inspection.There were no photos or returns received to assist with the investigation.This complaint cannot be confirmed.This product is not labeled as sterile.Prior to use, each mgit tube should be examined for evidence of contamination or damage.Discard any tubes if they appear unsuitable or exhibit fluorescence prior to use.For tubes that have been put into test and have suspect contamination, it is possible to reprocess contaminated mgit tubes.See the package insert for details for this procedure.Bd will continue to trend complaints for this defect.
Event or Problem Description
Report 4 of 5.It was reported when using the bd bbl¿ mgit¿ mycobacteria growth indicator tubes, contamination occurred with m.Tuberculosis complex in one (1) patient sample per identification from quest.No information could be provided by the customer regarding patient impact.

• Brand Name: BD BBL¿ 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: jo doyka ; 7 loveton circle; sparks, MD 21152 ; 4103164000
• MDR Report Key: 19955256
• Report Number: 1119779-2024-00590
• Device Sequence Number: 21057276
• Product Code: MDB
• UDI-Device Identifier: 30382902451137
• UDI-Public: (01)30382902451137
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K954932
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/27/2025

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: 11/23/2024
• Device Catalogue Number: 245113
• Device Lot Number: 3333194
• 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: 07/15/2024
• Supplement Date Received by Manufacturer: 01/27/2025
• Initial Report FDA Received Date: 08/09/2024
• Supplement Report FDA Received Date: 01/29/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/29/2023
• 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