MAUDE Adverse Event Report: BECTON, DICKINSON & CO. (Sparks) BD BBL¿ Columbia CNA Agar with 5% Sheep Blood; CULTURE MEDIA, SELECTIVE AND NON-DIFFERENTIAL

Catalog Number	221353
Medical Device Problem Codes	Contamination (1120); Incorrect, Inadequate or Imprecise Result or Readings (1535)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/26/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that while using bd bbl¿ columbia cna agar with 5% sheep blood, the customer observed mold contamination on the agar plate.No patient impact, health hazard, or adverse consequence was reported.
Additional Manufacturer Narrative
Investigation summary: introduction material #: 221353 batch #: 6160648 defect: customer reports contamination/foreign matter- mold background during manufacturing of material 221353, media is formulated and sent through a high temperature short time sterilizer to remove bioburden.The petri dishes are subjected to uv radiation to decrease bioburden.The petri dishes are filled in a positive pressure hepa filtered environment.The filled plates are cooled and immediately wrapped into sleeves to decrease the introduction of microbes.Sleeves are then packaged into cartons and then transferred to a refrigerated truck (2 to 8 degrees c) for shipment to the distributor.Bd distributors are provided with the storage guidelines for the shipping and handling of bd media of 2 to 8 degrees c in a dark place.Batch history review the batch history record for batch 6160648 was satisfactory and no quality notifications were generated during manufacturing and inspection.The release testing that is performed on this product does include bioburden testing.A sample of plates are incubated at 25 degrees c and at 35 degrees c for approximately 72 hours.All bioburden testing performed on this batch was satisfactory per bd internal procedures.Affected product does not have any sterility claims; the product is tested for bioburden prior to release to ensure that it conforms to product specifications.Returned material analysis there were no physical returns available to review for this complaint.There were three (3) photos available to review for this complaint.Complaint history the complaint history was reviewed for the material 221353, no trend was identified.Investigation retention samples for batch 6160648 were not available for investigation.Three photos were received for investigation.All three photos show plates which appear to have mold growth on the media.One photo shows a plate where the lot 6160648 and time stamp 1859 information are clearly visible, providing batch verification for 6160648.No physical return samples were available for investigation.Conclusion contamination was observed from review of the photos provided.The complaint can be confirmed.No complaint trends for this defect have been identified for this product; no actions are indicated at this time.Bd will continue to trend complaints for defects.

• Brand Name: BD BBL¿ Columbia CNA Agar with 5% Sheep Blood
• Common Device Name: CULTURE MEDIA, SELECTIVE AND NON-DIFFERENTIAL
• 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 ; +1(410)316-4000
• MDR Report Key: 50569357
• Report Number: 1119779-2026-01793
• Device Sequence Number: 9927906
• Product Code: JSJ
• UDI-Device Identifier: 10382902213533
• UDI-Public: (01)10382902213533(17)260914(10)6160648
• Combination Product (Y/N): N
• Initial Reporter State: KY
• Initial Reporter Country: US
• PMA/510(K) Number: NA
• 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
• Report Date (Section B): 09/01/2026

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: 09/14/2026
• Device Catalogue Number: 221353
• Device Lot Number: 6160648
• 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: 08/26/2026
• Initial Report FDA Received Date: 09/02/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/09/2026
• 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