MAUDE Adverse Event Report: BECTON, DICKINSON & CO. (SPARKS) BD BBL¿ CHOCOLATE II AGAR (GC II AGAR WITH HEMOGLOBIN AND ISOVITALEX¿); CULTURE MEDIA, FOR ISOLATION OF PATHOGENIC NEISSERIA

Model Number	221267
Medical Device Problem Code	Contamination (1120)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/22/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A device evaluation is anticipated but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.
Event or Problem Description
It was reported that the bd bbl¿ chocolate ii agar (gc ii agar with hemoglobin and isovitalex¿) plate was contaminated.There was no report of adverse user or patient impact.The following information was provided by the initial reporter: "contamination.".
Event or Problem Description
It was reported that the bd bbl¿ chocolate ii agar (gc ii agar with hemoglobin and isovitalex¿) plate was contaminated.There was no report of adverse user or patient impact.The following information was provided by the initial reporter: "contamination.".
Additional Manufacturer Narrative
H.6 investigation summary complaint investigation 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 1337228 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 1337228.Retention samples from batch 1337228 were not available for inspection.Four photos were received for investigation.Two photos each features the agar surface of a chocolate brown agar plate, however, the surface of the plate is not in focus in the photos.One photo shows the bottom of a plate from batch 1337228 (time stamp 0216) with the plate print featured for batch verification.The last photo shows the agar surface of a plate with small light-colored particles on the agar surface.The particles appear to be dried surface moisture rather than particulate or microbial growth.No return samples were received for investigation.This complaint can be confirmed for surface defects.The main component of prepared plated media is purified water.The purified water is held in an agar matrix in the media.Release of the purified water as the matrix contracts during temperature cycling and progression through shelf life is referred to as exudation.Exudate may contain media components that will present as texture or discoloration on the agar surface as the moisture dries.Dried surface moisture is considered a cosmetic defect.Trending data does not indicate actions at this time.Bd will continue to trend complaints for dried surface moisture.Risk management file review assessed the potential risk for the defect as severity s1 per baltrmppmgenpuraph, rev 02, id 6.11.10.

• Brand Name: BD BBL¿ CHOCOLATE II AGAR (GC II AGAR WITH HEMOGLOBIN AND ISOVITALEX¿)
• Common Device Name: CULTURE MEDIA, FOR ISOLATION OF PATHOGENIC NEISSERIA
• 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 ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 13765542
• Report Number: 1119779-2022-00431
• Device Sequence Number: 17401630
• Product Code: JTY
• UDI-Device Identifier: 10382902212673
• UDI-Public: 10382902212673
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• 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,Foreign,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/04/2023

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: 03/28/2022
• Device Model Number: 221267
• Device Catalogue Number: 221267
• Device Lot Number: 1337228
• 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: 02/22/2022
• Supplement Date Received by Manufacturer: 01/04/2023
• Initial Report FDA Received Date: 03/15/2022
• Supplement Report FDA Received Date: 01/10/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 12/03/2021
• 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