MAUDE Adverse Event Report: BECTON, DICKINSON & CO. (SPARKS) BD BBL COLUMBIA AGAR WITH 5% SHEEP BLOOD PLATE 100PK; CULTURE MEDIA, ENRICHED

Catalog Number	221263
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	05/08/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported while using bd bbl columbia agar with 5% sheep blood plate 100pk that staphylococcus and streptococcus were not exhibiting the expected hemolysis on the blood agar plate.There was no report of patient impact.
Additional Manufacturer Narrative
E1.Initial reporter address: (b)(6).Investigation summary: during manufacturing of material 221263, 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 for batch 4044761 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 agar with 5% sheep blood 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, and the only other complaint taken on batch 4044761 also was from (b)(6) for a different defect.Retention samples from batch 4044761 were not available for inspection.No return samples or photos were received for investigation of this complaint.This complaint cannot be confirmed for a performance defect.Bd will continue to trend complaints for performance.This mdr is being submitted as part of a retrospective review of records dating april 2023-2025, under capa 11910483.

• Brand Name: BD BBL COLUMBIA AGAR WITH 5% SHEEP BLOOD PLATE 100PK
• Common Device Name: CULTURE MEDIA, ENRICHED
• 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: 22740422
• Report Number: 1119779-2025-02684
• Device Sequence Number: 9306541
• Product Code: KZI
• UDI-Device Identifier: 10382902212635
• UDI-Public: (01)10382902212635(11)240213(17)240617(10)4044761
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• 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,Foreign,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 06/23/2025

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: 06/17/2024
• Device Catalogue Number: 221263
• Device Lot Number: 4044761
• 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: 05/08/2024
• Initial Report FDA Received Date: 08/07/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/13/2024
• 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