MAUDE Adverse Event Report: BECTON DICKINSON & CO. (SPARKS) BD BBL¿ COLUMBIA CNA AGAR W/5% SB// MACCONKEY II AGAR; CULTURE MEDIA, SELECTIVE AND NON-DIFFERENTIAL

Catalog Number	221601
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	06/25/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A device evaluation and/or device history review is anticipated but is not complete.Upon completion, a supplemental report will be filed.
Event or Problem Description
It was reported while using bd bbl¿ columbia cna agar w/5% sb// macconkey ii agar 3 samples had insufficient growth of gram negative bacteria on the macconkey side of the plate.There was no health impact or consequences reported.
Event or Problem Description
It was reported while using bd bbl¿ columbia cna agar w/5% sb// macconkey ii agar 3 samples had insufficient growth of gram negative bacteria on the macconkey side of the plate.There was no health impact or consequences reported.
Additional Manufacturer Narrative
Investigation summary: during manufacturing of material 221601, 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.The batch history record review for batch 4116876 was satisfactory and no quality notifications were generated during manufacturing and inspection.All batches are tested prior to release and results reported on the certificate of analysis which can be obtained at www.Bd.Com/regdocs.Columbia can//macconkey ii i plate is stability tested biennially for biological performance to ensure satisfactory performance throughout shelf life with the organisms that are reported on the certificate of analysis.All performance testing on this batch was satisfactory at the time of release.The complaint history was reviewed, there are no other complaints taken on this batch 4116876 for this defect.There were no retention samples available for investigation of this complaint.No photos, no returns or retains were available for investigation of this complaint.This complaint cannot be confirmed.No complaint trends for this defect have been identified; no actions are indicated at this time.Bd will continue to trend complaints for performance.
Event or Problem Description
It was reported while using bd bbl¿ columbia cna agar w/5% sb// macconkey ii agar, there were an unknown number of plates with insufficient growth.There was no report of patient impact.
Additional Manufacturer Narrative
The following fields have been updated: b5.It was reported while using bd bbl¿ columbia cna agar w/5% sb// macconkey ii agar, there were an unknown number of plates with insufficient growth.There was no report of patient impact.This supplemental mdr is being submitted as part of a retrospective review of records dating april 2023¿2025, under capa 11910483.

• Brand Name: BD BBL¿ COLUMBIA CNA AGAR W/5% SB// MACCONKEY II AGAR
• 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: jo doyka ; 7 loveton circle; sparks, MD 21152 ; 4103164000
• MDR Report Key: 19824537
• Report Number: 1119779-2024-00561
• Device Sequence Number: 15623068
• Product Code: JSJ
• UDI-Device Identifier: 00382902216018
• UDI-Public: (01)00382902216018(11)240425(17)240813(10)4116876
• Combination Product (Y/N): N
• Initial Reporter State: OH
• 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,Followup,Followup
• Report Date (Section B): 08/14/2025

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: 08/13/2024
• Device Catalogue Number: 221601
• Device Lot Number: 4116876
• 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: 06/25/2024
• Supplement Date Received by Manufacturer: 01/13/2025; 08/21/2025
• Initial Report FDA Received Date: 07/25/2024
• Supplement Report FDA Received Date: 02/03/2025; 08/21/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/25/2024
• 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