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

Model Number	221239
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	02/09/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A device evaluation and/or device history review is anticipated, but is not complete.Upon completion, a supplemental report will be filed.
Event or Problem Description
It was reported that while using bd bbl¿ trypticase¿ soy agar with 5% sheep blood (tsa ii) contamination was observed by the laboratory personnel.There was no indication that results were reported out and there was no report of patient impact.
Event or Problem Description
It was reported that while using bd bbl¿ trypticase¿ soy agar with 5% sheep blood (tsa ii) contamination was observed by the laboratory personnel.There was no indication that results were reported out and there was no report of patient impact.
Additional Manufacturer Narrative
Investigation: during manufacturing of material 221239, 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 0289988 was satisfactory at time of release 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 three other complaints have been taken on this batch for contamination.Retention samples from batch 0289988 were not available for inspection.One photo was received in lieu of returns for investigation.The photo shows the surface of two opened plates with a large bacterial colony on each.No plate prints or product labels are visible for batch verification in the photo.It is also noted that batch 0289988 expired on 2021-02-01 and this complaint was taken on february 09, 2021.Bd makes no claims on expired product.The photo provided cannot confirm the complaint.However, returns from another customer from batch 0289988 showed contamination prior to the expiration date.This complaint can be confirmed by the previous complaint.Bd will continue to trend complaints for contamination.Due to the low defect rate reported for this batch, no actions are indicated at this time.Bd continues to actively monitor defects for all products and identify opportunities for quality improvements.

• 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
• MDR Report Key: 11446577
• Report Number: 1119779-2021-00442
• Device Sequence Number: 4048566
• Product Code: JSG
• UDI-Device Identifier: 10382902212390
• UDI-Public: 10382902212390
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• 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): 08/03/2021

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: 02/01/2021
• Device Model Number: 221239
• Device Catalogue Number: 221239
• Device Lot Number: 0289988
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 02/09/2021
• Supplement Date Received by Manufacturer: 08/03/2021
• Initial Report FDA Received Date: 03/09/2021
• Supplement Report FDA Received Date: 08/16/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1