MAUDE Adverse Event Report: BECTON DICKINSON & CO. (SPARKS) BD BBL¿ TRYPTICASE¿ SOY AGAR (SOYBEAN-CASEIN DIGEST AGAR); CULTURE MEDIA, NON-SELECTIVE AND NON-DIFFERENTIAL

Model Number	221283
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	07/05/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that while using bd bbl¿ trypticase¿ soy agar (soybean-casein digest agar) there was biological contamination of one plate.There was no patient impact reported.The following information was provided by the initial reporter: "customer reports a contaminated plate.1 plate so far found contaminated.Colony is off-white to beige located on the surface.".
Additional Manufacturer Narrative
E.1.Initial reporter addr 1:(b)(6).H.3.A device evaluation and/or device history review is anticipated but is not complete.Upon completion, a supplemental report will be filed.
Additional Manufacturer Narrative
H.6.Investigation summary: during manufacturing of material 221283, 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 3122987 was satisfactory and no quality notifications were generated during manufacturing and inspection.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 for batch 3122987.No retention samples for batch 3122987 were available for inspection.Four photos were received for investigation of this complaint.The first photo shows a plate from batch 3122987 (time stamp 1706) with contamination present on the edge of the agar in the plate.The second photo shows an empty sleeve from batch 3122987 and no plates with contamination can be seen in the photo.The third photo appears to be the same as the second photo.The fourth photo appears to show the same plate as the first photo and the contamination is present on the surface of the agar.No return samples were received for investigation of this complaint.This complaint can be confirmed.Bd has identified a contamination trend for this product and the investigation found opportunities for bioburden reduction in the manufacturing process.A capa (corrective and preventative actions) has been initiated and involves implementing additional cleaning events and evaluation of manufacturing procedures focused on in-process bioburden reduction.Additional trainings are part of the implementation with an ongoing training review for cleaning processes.Improvement in observation of contamination is expected as the capa progresses.H3 other text : see h.10.
Event or Problem Description
It was reported that while using bd bbl¿ trypticase¿ soy agar (soybean-casein digest agar) there was biological contamination of one plate.There was no patient impact reported.The following information was provided by the initial reporter: "customer reports a contaminated plate.1 plate so far found contaminated.Colony is off-white to beige located on the surface.".

• Brand Name: BD BBL¿ TRYPTICASE¿ SOY AGAR (SOYBEAN-CASEIN DIGEST AGAR)
• 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: phillip emmert ; 5859 farinon drive; san antonio, TX 78249 ; 8448235433
• MDR Report Key: 17313021
• Report Number: 1119779-2023-00769
• Device Sequence Number: 6095653
• Product Code: JSG
• UDI-Device Identifier: 10382902212833
• UDI-Public: 10382902212833
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: PREAMENDMENT
• 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,Followup
• Report Date (Section B): 12/08/2023

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: 09/05/2023
• Device Model Number: 221283
• Device Catalogue Number: 221283
• Device Lot Number: 3122987
• 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: 07/05/2023
• Supplement Date Received by Manufacturer: 12/08/2023
• Initial Report FDA Received Date: 07/12/2023
• Supplement Report FDA Received Date: 12/29/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/02/2023
• Is the Device Labeled for Single Use? (Y/N): No
• 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