MAUDE Adverse Event Report: BECTON, DICKINSON & CO. (SPARKS) BD BBL¿ TRYPTICASE¿ SOY AGAR WITH 5% SHEEP BLOOD (TSA II); CULTURE MEDIA, NON-SELECTIVE AND NON-DIFFERENTIAL

Catalog Number	221261
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	07/22/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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 and during use of bd bbl¿ trypticase¿ soy agar with 5% sheep blood (tsa ii), white fungal contamination was observed.Uninoculated plates, plates used for non patient testing, and an unknown number of plates used with an unspecified number of patient samples were involved.No confirmatory testing was performed and the fungal contaminate was not identified.There were no health impact or consequences reported.
Event or Problem Description
It was reported before and during use of bd bbl¿ trypticase¿ soy agar with 5% sheep blood (tsa ii), white fungal contamination was observed.Uninoculated plates, plates used for non patient testing, and an unknown number of plates used with an unspecified number of patient samples were involved.No confirmatory testing was performed and the fungal contaminate was not identified.There were no health impact or consequences reported.
Additional Manufacturer Narrative
Investigation summary: during manufacturing of material 221261, 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 5107136 was satisfactory and no quality notifications were generated during manufacturing and inspection.A review of quality notifications and complaint data for the manufacturing plant, which includes material 221261, revealed no batches or materials exhibiting contamination trends during calendar year 2025.Batch 5107136 was manufactured in april of 2025, and no contamination-related complaint trends have been reported.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.However, this does not ensure that the end-user will not receive a contaminated plate.The complaint history was reviewed, and no other complaints have been taken on batch 5107136 for this defect.There were no retention samples available for investigation of this complaint.A total of six photos were submitted by the customer to support their complaint.The observations from each photo are as follows: one photo show two contaminated plates.The surface of one plate is clearly visible, revealing multiple small fungal colonies.One photo displays a contaminated plate with multiple large fungal colonies.One photo shows one plate with two large bacterial colonies.One photo is taken from underneath a single plate.Multiple large colonies are visible, but the contamination type cannot be determined from this angle.One photo shows a plate with multiple large fungal colonies.One photo shows a plate with 2 large fungal colonies.No returns were provided for this investigation.This complaint can be confirmed based on the photos provided.As part of the investigation manufacturing records¿including equipment logs, cleaning documentation, and environmental monitoring¿related to the production of batch 5107136 was reviewed.No definitive root cause was identified for the contamination observed in this batch.While the root cause remains undetermined, the contamination event was confirmed to be isolated to products shipped to baylor scott & white research institute.Based on the current findings no corrective actions are identified at this time.Bd will continue to monitor and trend contamination-related complaints to ensure ongoing product quality.

• Brand Name: BD BBL¿ TRYPTICASE¿ SOY AGAR WITH 5% SHEEP BLOOD (TSA II)
• Common Device Name: CULTURE MEDIA, NON-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 ; 4103164000
• MDR Report Key: 22844033
• Report Number: 1119779-2025-03714
• Device Sequence Number: 18507522
• Product Code: JSG
• UDI-Device Identifier: 10382902212611
• UDI-Public: (01)10382902212611(17)250811(10)5107136
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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
• Report Date (Section B): 11/14/2025

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: 08/11/2025
• Device Catalogue Number: 221261
• Device Lot Number: 5107136
• 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: 07/22/2025
• Supplement Date Received by Manufacturer: 11/14/2025
• Initial Report FDA Received Date: 08/19/2025
• Supplement Report FDA Received Date: 12/03/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/17/2025
• 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