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

Catalog Number 221291

Device Problem Improper or Incorrect Procedure or Method (2017)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 07/25/2023

Event Type  malfunction  

Manufacturer Narrative

Initial reporter phone: (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.

Event Description

It was reported that bd bbl¿ trypticase¿ soy agar with 5% sheep blood (tsa ii) // macconkey ii agar is contaminated.This occurred 225 times.The following information was provided by the initial reporter: medium contaminated.Plates are contaminated.

Manufacturer Narrative

H6.Investigation summary: during manufacturing of material 221291, 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 3142623 was satisfactory per internal procedures.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 other complaints have been received on batch 3142623 for contamination.No retention samples for batch 3142623 were available for inspection.There were three photos received for investigation of this complaint.The first photo shows two plates (batch number 3142623 time stamp 0329 can be seen on one plate) with contamination on the agar bed surface and within the agar.The second photo shows four plates (batch number 3142623 can be seen on three plates and time stamps 0329 and 0415 are visible) with contamination on the agar surface and within the agar.The third photo shows two plates from batch 3142623 (time stamps 0408 and 0415 are visible) with contamination within the agar.No return samples were available for investigation.This complaint can be confirmed for contamination.Bd has identified a contamination trend for this product and the investigation found opportunities for bioburden reduction in the manufacturing process.Bd will continue to trend complaints for contamination.

Event Description

It was reported that bd bbl¿ trypticase¿ soy agar with 5% sheep blood (tsa ii) // macconkey ii agar is contaminated.This occurred 225 times.The following information was provided by the initial reporter: medium contaminated.Plates are contaminated.

• Brand Name: BD BBL¿ TRYPTICASE¿ SOY AGAR WITH 5% SHEEP BLOOD (TSA II) // MACCONKEY II AGAR
• Type of Device: 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: jennifer suh ; 5859 farinon drive; san antonio, TX 78249 ; 8448235433
• MDR Report Key: 17483451
• MDR Text Key: 320634024
• Report Number: 1119779-2023-00857
• Device Sequence Number: 1
• Product Code: JSG
• UDI-Device Identifier: 10382902212918
• UDI-Public: 10382902212918
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: PREAMENDMENT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 10/06/2023

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
• Device Operator: Other
• Device Expiration Date: 09/05/2023
• Device Catalogue Number: 221291
• Device Lot Number: 3142623
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/25/2023
• Initial Date FDA Received: 08/08/2023
• Supplement Dates Manufacturer Received: 10/06/2023
• Supplement Dates FDA Received: 10/10/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/22/2023
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1