MAUDE Adverse Event Report: BECTON DICKINSON & CO. (SPARKS) BD BBL¿ MGIT¿ MYCOBACTERIA GROWTH INDICATOR TUBES, 7ML; SYSTEM, BLOOD CULTURING

Catalog Number	245122
Medical Device Problem Code	Contamination (1120)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/03/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
E.1.Additional initial reporter phone #:(b)(6).Investigation summary: material 245122 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 3324857 was satisfactory per internal procedures.In process checks are performed during manufacturing at designated intervals per procedures.Checks for fill volume were complete and within specifications per procedures.This product is not labeled as sterile.Media should be inspected prior to use and should not be used if medium shows evidence of contamination, drying, cracking or other signs of deterioration.The complaint history was reviewed, and there are no other complaints taken on batch 3324857 for low fill/contamination.Retentions (100 tubes) were available for inspection.There were no low filled nor contamination defect observed in the retention samples.1 photo was received for this complaint.Tube shown to be underfilled and contaminated.Batch number and expiration date are visible (3324857/2025-05-21).No returns available for this investigation.This complaint can be confirmed for low fill and contamination.No complaint trends for this defect have been identified; no actions are indicated at this time.Bd will continue to trend complaints for low fill and contamination.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, 7ml, a tube was contaminated with mold.There was no report of patient impact.

• Brand Name: BD BBL¿ MGIT¿ MYCOBACTERIA GROWTH INDICATOR TUBES, 7ML
• 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: 22977601
• Report Number: 1119779-2025-04927
• Device Sequence Number: 9549649
• Product Code: MDB
• UDI-Device Identifier: 30382902451229
• UDI-Public: (01)30382902451229(11)231120(17)250521(10)3324857
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• PMA/510(K) Number: K974883
• 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): 07/10/2025

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: 05/21/2025
• Device Catalogue Number: 245122
• Device Lot Number: 3324857
• 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: 05/03/2024
• Initial Report FDA Received Date: 09/05/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/20/2023
• 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