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

Catalog Number	222239
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	01/19/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
"investigation summary: during manufacturing of material 222239, 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 complaint history was reviewed, and no other complaints have been taken on batch 3320027.No retention samples for this batch were available for investigation.No return samples were received for investigation of this complaint.Five photos were received for investigation of this complaint.Photos show contamination in batch 3320027 with timestamp 1510 and 1608 visible in some of the photos.This complaint can be confirmed.No complaint trends have been identified on this product for this defect.Bd will continue to trend complaints for 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¿ chromagar¿ orient/tsa ii w/5% sb, there was a false result due to contamination.There was no report of patient impact.

• Brand Name: BD BBL¿ CHROMAGAR¿ ORIENT/TSA II W/5% SB
• Common Device Name: CULTURE MEDIA, NON-SELECTIVE AND 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 ; 4103164000
• MDR Report Key: 22584648
• Report Number: 1119779-2025-01882
• Device Sequence Number: 4540264
• Product Code: JSH
• UDI-Device Identifier: 10382902222399
• UDI-Public: (01)10382902222399(11)231116(17)240211(10)3320027
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 06/12/2025

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: 02/11/2024
• Device Catalogue Number: 222239
• Device Lot Number: 3320027
• 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: 02/09/2024
• Initial Report FDA Received Date: 07/24/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/16/2023
• 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