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

Catalog Number	221270
Medical Device Problem Code	Contamination (1120)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/15/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H.3.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
T was reported that prior to use with 200 bd bbl¿ macconkey ii agar the plates were discovered to be contaminated.The following information was provided by the initial reporter: on 8/15/2023 we received 2,600 macconkey ii plates and found that 200 were contaminated.
Additional Manufacturer Narrative
H.6.Investigation summary: the batch history record for batch 3165519 was reviewed 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 for batch 3165519 was reviewed and no other complaints have been taken on batch 3165519.Four photos were received for investigation of this complaint.The first photo shows a plate from batch 3165519 (time stamp 2047) with contamination on the plate.The second photo shows two plates (for the batch number and time stamp are not visible, the other is from batch 3165519 time stamp 2046) and both plates have visible contamination.The third photo shows a plate from batch 3165519 (time stamp 2046) with discoloration consistent with contamination.The fourth photo shows a sleeve of plates from batch 3165519 (time stamps not visible) and no contamination is visible on the plates.No return samples were received for investigation.This complaint can be confirmed.Bd has identified a contamination trend for this product and the investigation found opportunities for bioburden reduction in the manufacturing process.
Event or Problem Description
It was reported that prior to use with 200 bd bbl¿ macconkey ii agar the plates were discovered to be contaminated.The following information was provided by the initial reporter: on (b)(6) 2023 we received 2,600 macconkey ii plates and found that 200 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: jennifer suh ; 9450 south state street; sandy, UT 84070 ; 8448235433
• MDR Report Key: 17663343
• Report Number: 1119779-2023-00962
• Device Sequence Number: 6160613
• 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): 10/26/2023

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: 09/18/2023
• Device Catalogue Number: 221270
• Device Lot Number: 3165519
• 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: 08/23/2023
• Supplement Date Received by Manufacturer: 10/26/2023
• Initial Report FDA Received Date: 08/31/2023
• Supplement Report FDA Received Date: 11/14/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/14/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• 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