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	07/09/2025
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 while using bd bbl¿ trypticase¿ soy agar with 5% sheep blood (tsa ii), excessive moisture was present.The user alleged the excessive moisture led to contamination and a patient receiving an antibiotic due to a bacillus species (not anthracis) identified from culture.It was noted that the user rarely identified bacillus species (not anthracis) from this agar plate.Confirmatory testing included gram stain, subculture, vitek 2, and maldi-tof.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 for batch 5114561 was satisfactory and no quality notifications were generated during manufacturing and inspection.The release testing that is performed on this product does include physical attribute testing.A sample of plates are incubated at 25 degrees c and at 35 degrees c for approximately 72 hours.They are tested for physical attributes and contamination prior to release to ensure that they conform to product specifications.All physical attribute and 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; there is no other complaint taken on this batch 5114561.There were no retention samples available for investigation of this complaint.Two photos were received for investigation of this complaint.¿ one photo shows one sleeve of sheep blood media with visible condensation.¿ a second photo shows the back of a tsa 5% sb plate from batch 5114561.No return samples were available for investigation.This complaint can be confirmed for excessive moisture, no evidence of contamination was presented for this investigation therefore the complaint for contamination cannot be confirmed.No complaint trends for these defects have been identified; no actions are indicated at this time.Bd will continue to trend complaints for defects.
Event or Problem Description
It was reported while using bd bbl¿ trypticase¿ soy agar with 5% sheep blood (tsa ii), excessive moisture was present.The user alleged the excessive moisture led to contamination and a patient receiving an antibiotic due to a bacillus species (not anthracis) identified from culture.It was noted that the user rarely identified bacillus species (not anthracis) from this agar plate.Confirmatory testing included gram stain, subculture, vitek 2, and maldi-tof.There were no health impact or consequences reported.

• 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: 22750878
• Report Number: 1119779-2025-02772
• Device Sequence Number: 18305660
• Product Code: JSG
• UDI-Device Identifier: 10382902212611
• UDI-Public: (01)10382902212611(17)250818(10)5114561
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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): 08/27/2025

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: 08/18/2025
• Device Catalogue Number: 221261
• Device Lot Number: 5114561
• 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: 07/09/2025
• Supplement Date Received by Manufacturer: 08/27/2025
• Initial Report FDA Received Date: 08/08/2025
• Supplement Report FDA Received Date: 09/18/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/08/2025
• 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