MAUDE Adverse Event Report: BECTON, DICKINSON & CO. (SPARKS) SEE H.10

Model Number	221267
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	02/11/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that bd bbl¿ chocolate ii agar (gc ii agar with hemoglobin and isovitalex¿) fungal growth was found.The following information was provided by the initial reporter: upon opening of the packaging of our 221267 bbl plated media, fungal growth is seen in the inside of the plate.
Additional Manufacturer Narrative
Medical device brand name: bd bbl¿ chocolate ii agar (gc ii agar with hemoglobin and isovitalex¿) common device name: culture media, for isolation of pathogenic neisseria 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
H6.During manufacturing of material 221267, 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 2305646 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 on batch 2305646 for soft agar.No retention samples for batch 2305646 were available for inspection.There were two photos received for investigation of this complaint.The first photo shows an opened sleeve of plates from batch 2305646.The second photo shows a plate from batch 2305646 with contamination on the agar surface (time stamp not visible).No return samples were available for investigation.This complaint can be confirmed for contamination.No complaint trends for this defect have been identified for this product; no actions are indicated at this time.Bd will continue to trend complaints defects.H3 other text : see h10.
Event or Problem Description
It was reported that bd bbl¿ chocolate ii agar (gc ii agar with hemoglobin and isovitalex¿) fungal growth was found.The following information was provided by the initial reporter: upon opening of the packaging of our 221267 bbl plated media, fungal growth is seen in the inside of the plate.

• Brand Name: SEE H.10
• Common Device Name: SEE H.10
• 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: 16444991
• Report Number: 1119779-2023-00182
• Device Sequence Number: 5860128
• Product Code: JTY
• UDI-Device Identifier: 10382902212673
• UDI-Public: 10382902212673
• Combination Product (Y/N): N
• Initial Reporter Country: RP
• PMA/510(K) Number: NA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/21/2023

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: 02/28/2023
• Device Model Number: 221267
• Device Catalogue Number: 221267
• Device Lot Number: 2305646
• 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: 02/11/2023
• Supplement Date Received by Manufacturer: 04/20/2023
• Initial Report FDA Received Date: 02/27/2023
• Supplement Report FDA Received Date: 05/03/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/01/2022
• 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