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	False Positive Result (1227)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/17/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
B3: date of event is unknown.The date received by manufacturer has been used for this field.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 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 batch history record review for batch 3025464 was satisfactory and no quality notifications were generated during manufacturing and inspection.Filling, torquing, and autoclaving processes were within specifications.In process checks were performed at the designated intervals.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.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.Retention tubes were placed into incubation to test for contamination at 20 to 25 degrees c (5 tubes) and 33 to 37 degrees c (5 tubes).At seven days incubation, no microbial growth was observed in 10/10 incubated retention tubes.The complaint history was reviewed, and one other complaint has been taken on batch 3025464 for contamination from shiga prefectural general hospital.No return samples or photos were received for investigation of this complaint.Return samples and photos from the other complaint on this batch (complaint number (b)(4) did not confirm the complaint.This complaint cannot be confirmed.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 bbl¿ mgit¿ mycobacteria growth indicator tubes, 4ml (100/sp), there was a false positive result.There was no report of patient impact.

• 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: 22922573
• Report Number: 1119779-2025-04596
• Device Sequence Number: 13319597
• 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?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/17/2023
• Initial Report FDA Received Date: 08/29/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/25/2023
• Is the Device Labeled for Single Use? (Y/N): No
• 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