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 08/01/2023

Event Type  malfunction  

Event Description

It was reported that while using bd bbl¿ trypticase soy agar with 5% sheep blood (tsa ii), there was contamination of 7 plates.No patient impact reported.The following information was provided by the initial reporter: "customer reporting agar fallout, contamination, clearing of agar around the edge, and uneven filling in plates 221261 lot 3129327 - plate trypticase soy agar 5% sb 100 ea.(2) contamination: 7.".

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 while using bd bbl¿ trypticase soy agar with 5% sheep blood (tsa ii), there was contamination of 7 plates.No patient impact reported.The following information was provided by the initial reporter: "customer reporting agar fallout, contamination, clearing of agar around the edge, and uneven filling in plates 221261 lot 3129327 - plate trypticase soy agar 5% sb 100 ea.(2) contamination: 7.".

Manufacturer Narrative

H3.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 3129327 was reviewed and was satisfactory per internal procedures.The release testing that is performed on this product does include physical attribute and bioburden testing.A sample of plates are incubated at 25 degrees c and at 35 degrees c for approximately 72 hours.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 for batch 3129327 was reviewed and was satisfactory per internal procedures.No retention samples for batch 3129327 were available for inspection.Four photos were received for investigation of this complaint.The first photo shows a plate from batch 3129327 (time stamp 0358) and no defects in relation to this complaint can be seen in this photo.The second photo shows four plates (batch numbers and time stamps not visible) where three of the plates have hemolysis and the fourth plate has contamination.The third photo shows two plates (batch number and time stamp not visible) where the plate on the left appears to be dried and the plate on the right has no apparent defects.The fourth photo shows a stack of plates from batch 3129327 (time stamps are not visible) and there are no defects visible in the photo.No return samples were received for investigation.This complaint can be confirmed for contamination/hemolysis and dried media.This complaint cannot be confirmed for media fall out and uneven fill.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.

• 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: 17604338
• MDR Text Key: 321757363
• Report Number: 1119779-2023-00921
• 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: 10/23/2023

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: 09/07/2023
• Device Catalogue Number: 221261
• Device Lot Number: 3129327
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/09/2023
• Initial Date FDA Received: 08/23/2023
• Supplement Dates Manufacturer Received: 10/23/2023
• Supplement Dates FDA Received: 10/25/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/09/2023
• 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