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

Catalog Number	245116
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	05/12/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The information for the additional 510k is as follows: g4.Pma/510(k)#: k974883.A device evaluation is anticipated but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.
Event or Problem Description
It was reported before using bd bbl¿ mgit¿ oadc, one (1) sealed oadc vial was observed to have fungal contamination.There were no health impact or consequences reported.
Additional Manufacturer Narrative
Investigation summary - bactec mgit oadc enrichment (material 245116) is manufactured by mixing media components into a homogenous solution.The solution is then sterile filtered and dispensed into vials; stoppers are manually placed in the vial opening; septum caps are manually placed on top of the stopper and then mechanically crimped per standard operating procedure.Six bactec mgit oadc enrichment vials are then manually packaged into a carton to complete the kit.The batch history record for mgit 960 growth supplement batch 4284940 was satisfactory per internal procedures.Qc inspection and testing were satisfactory at time of release.The complaint history was reviewed and there are no other complaints on batch 4284940.For this product, retention samples are maintained as individual components and not tested as the photos can confirm the complaint defect.Two photos were received to assist with this complaint.Both photos showed supplement vial batch 4284940 exp 2026-04-10 with a white mass floating in the media.No returns were received to assist with this complaint investigation.This complaint can be confirmed for contamination from the photos received.No complaint trends were identified for this product; no actions are indicated at this time.Bd will continue to trend complaints for contamination.
Event or Problem Description
It was reported before using bd bbl¿ mgit¿ oadc, one (1) sealed oadc vial was observed to have fungal contamination.There were no health impact or consequences reported.

• Brand Name: BD BBL¿ MGIT¿ OADC
• 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: 22135586
• Report Number: 1119779-2025-00534
• Device Sequence Number: 8500178
• Product Code: MDB
• UDI-Device Identifier: 30382902451168
• UDI-Public: (01)30382902451168(11)241010(17)260410(10)4284940
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• 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,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/16/2025

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: 04/10/2026
• Device Catalogue Number: 245116
• Device Lot Number: 4284940
• 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: 05/12/2025
• Supplement Date Received by Manufacturer: 07/16/2025
• Initial Report FDA Received Date: 06/03/2025
• Supplement Report FDA Received Date: 07/22/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/10/2024
• 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