MAUDE Adverse Event Report: BECTON, DICKINSON & CO. (SPARKS) BD BBL¿ MGIT¿ MYCOBACTERIA GROWTH INDICATOR TUBES, 4ML (100/SP); 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	10/27/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported while using bd bbl¿ mgit¿ mycobacteria growth indicator tubes, 4ml (100/sp), there was false result due to contamination.There was no report of patient impact.
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 3025464 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 one other complaint has been taken on batch 3025464.Retention samples from batch 3025464 (100 tubes) were available for inspection.There were zero contamination defects observed in 100/100 retention tubes from visual inspection.Ten (10) uninoculated retention tube was placed into incubation to test for contamination.Five (5) tubes were placed into the 20 to 25 degrees celsius incubator and five (5) tubes were placed into the 33-to-37-degree celsius incubator.At seven days incubation, there were no traces of microbial growth in the incubated retention tubes.There were three (3) photos received to assist in the investigation of batch 3025464.Six (6) unused returns were received in a zip lock bag in a box with air bubbles to assist with the investigation.Three (3) returned unused tubes were placed into the 20 to 25 degrees celsius incubator and three returned unused tubes were placed into the 33-to-37-degree celsius incubator.At twenty-two (22) days of incubation, there was no growth in the 6 incubated tubes.There were three photos received to assist in the investigation of batch 3025464.One photo was of an open box of tubes with on the top of the caps visible with no batch identification.There was one photo of a tube on its side with the label visible (batch 3025464).The third photo was of a microscope slide with writing.There were forty-eight (48) tubes and one box with a glass slide returned for investigation of batch 3025464.The tubes were in a 100-pack carton, padded with bubble wrap in a zip lock bag inside of a box.The box was with returns for three other complaints.Twenty-four (24) returned tubes were incubated in a 20 to 25 degrees celsius incubator and 24 returned tubes were incubated in a 33 to 37 degrees celsius incubator for 25 days.At 25 days, the was no growth in the 48 tubes.The photos do not confirm contamination.The incubated retention tubes nor returns exhibited no growth after incubation.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.This mdr is being submitted as part of a retrospective review of records dating april 2023¿2025, under capa 11910483.

• Brand Name: BD BBL¿ MGIT¿ MYCOBACTERIA GROWTH INDICATOR TUBES, 4ML (100/SP)
• 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: 22923673
• Report Number: 1119779-2025-04633
• Device Sequence Number: 15743816
• Product Code: MDB
• UDI-Device Identifier: 30382902451137
• UDI-Public: (01)30382902451137(11)230125(17)240120(10)3025464
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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,Foreign,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 07/14/2025

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: 01/20/2024
• Device Catalogue Number: 245113
• Device Lot Number: 3025464
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/17/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/30/2023
• Initial Report FDA Received Date: 08/29/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/25/2023
• 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