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

Device Problem Contamination (1120)

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

Event Date 07/31/2023

Event Type  malfunction  

Manufacturer Narrative

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 prior to using bd bbl¿ trypticase soy agar with 5% sheep blood (tsa ii), one plate in one pack was contaminated with mold.No patient impact reported.The following information was provided by the initial reporter: "contamination noticed in an unopened sleeve in the middle of the stack.Only one plate in one package observed with mold.Contamination noticed 'when we started to test it for growth promotion before we release it for use on 7/31/2023.'".

Manufacturer Narrative

H.6 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 3143356 was reviewed and 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 for batch 3143356 and other complaint have been received for contamination.No retention samples for batch 3143356 were available for inspection.Three photos were received for investigation of this complaint.The first photo shows an unopened sleeve of plates from batch 3143356 (time stamps not visible) and one plate in the sleeve appears to be contaminated.The second photo shows a sleeve of plates (batch number and time stamp not visible) with one plate appearing to be contaminated.The third photo appears to show the same sleeve of plates from the first photo.No return samples were received 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.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.Bd will continue to trend complaints for contamination.

Event Description

It was reported that prior to using bd bbl¿ trypticase soy agar with 5% sheep blood (tsa ii), one plate in one pack was contaminated with mold.No patient impact reported.The following information was provided by the initial reporter: "contamination noticed in an unopened sleeve in the middle of the stack.Only one plate in one package observed with mold.Contamination noticed 'when we started to test it for growth promotion before we release it for use on 7/31/2023.'".

• Brand Name: BD BBL¿ TRYPTICASE SOY AGAR WITH 5% SHEEP BLOOD (TSA II)
• 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: 17510697
• MDR Text Key: 321062770
• Report Number: 1119779-2023-00873
• Device Sequence Number: 1
• Product Code: JSG
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PREAMENDMENT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 10/18/2023

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: 09/20/2023
• Device Catalogue Number: 221261
• Device Lot Number: 3143356
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/04/2023
• Initial Date FDA Received: 08/11/2023
• Supplement Dates Manufacturer Received: 10/18/2023
• Supplement Dates FDA Received: 10/23/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/23/2023
• 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