MAUDE Adverse Event Report: BECTON, DICKINSON & CO. (SPARKS) BD BBL MACCONKEY II AGAR; CULTURE MEDIA, SELECTIVE AND DIFFERENTIAL

Model Number	221270
Medical Device Problem Code	Contamination of Device Ingredient or Reagent (2901)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/07/2022
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 when using the media, bd bbl macconkey ii agar, biological contamination was observed.There was no report of adverse patient impact.The following information was provided by the initial reporter: "it was reported by the customer that found about 80 plates that were contaminated.".
Additional Manufacturer Narrative
H.6 investigation summary during manufacturing of material 221270, 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 was revied for batch 2109300 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 one other complaint has been taken on batch 2109300 for contamination.Retention samples from batch 2109300 were not available for investigation.Four photos were received.Photo one (lot 2109300 timestamp 1480) shows one plate with a large red colony and a smaller seeming colony visible on the plate.Photo two shows one plate (lot unreadable timestamp 0041) with many red colonies visible on the agar surface of the plate.Photo three shows a sleeve from lot 2109300.Photo four show one plate (lot 2109300 timestamp 1480) with four colonies on the plate.The complaint can be confirmed.The batch number in the photos show the contamination on the surface of the plate.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 for contamination.H3 other text : see h.10.
Event or Problem Description
It was reported when using the media, bd bbl macconkey ii agar, biological contamination was observed.There was no report of adverse patient impact.The following information was provided by the initial reporter: "it was reported by the customer that found about 80 plates that were contaminated.".

• Brand Name: BD BBL MACCONKEY II AGAR
• Common Device Name: CULTURE MEDIA, SELECTIVE AND 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: phillip emmert ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 14939051
• Report Number: 1119779-2022-00959
• Device Sequence Number: 4995154
• Product Code: JSI
• UDI-Device Identifier: 10382902212703
• UDI-Public: 10382902212703
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• 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): 01/20/2023

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: 07/20/2022
• Device Model Number: 221270
• Device Catalogue Number: 221270
• Device Lot Number: 2109300
• 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: 06/07/2022
• Supplement Date Received by Manufacturer: 01/20/2023
• Initial Report FDA Received Date: 07/06/2022
• Supplement Report FDA Received Date: 01/24/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/19/2022
• 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