MAUDE Adverse Event Report: BECTON DICKINSON & CO. (SPARKS) BD BBL¿ CDC ANAEROBE 5% SHEEP BLOOD AGAR; CULTURE MEDIA, NON-SELECTIVE AND NON-DIFFERENTIAL

Catalog Number	221734
Medical Device Problem Code	Contamination (1120)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/19/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported while using bd bbl¿ cdc anaerobe 5% sheep blood agar, media was contaminated.There was no report of patient impact.
Additional Manufacturer Narrative
D4 medical device lot #: 3161027 was reported, however, this is not a lot number manufactured for the reported catalog number.D4.Medical device expiration date: unknown.H4.Device manufacture date: unknown.Investigation summary: the batch number provided for investigation was 3161027.Manufacturing records were reviewed and there is no record of batch 3161027 made of material 221734.An expiration date of 2023-07-25 was provided.From review of batches of material 221734 it appears that subject batch for this investigation is 3101027.The batch history record for batch 3101027 was satisfactory and no quality notifications were generated during manufacturing and investigation.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 3101027.Retention samples from batch 3101027 were not available for inspection.One photo was received for investigation.The photo shows the agar surface of eight plates with growth.No plate print or product labels are visible in the photo for batch verification.Without batch verification, the photo cannot confirm the complaint.No return samples were received for investigation.This complaint cannot be confirmed.Bd will continue to trend complaints for contamination.This mdr is being submitted as part of a retrospective review of records dating april 2023-2025, under capa 11910483.

• Brand Name: BD BBL¿ CDC ANAEROBE 5% SHEEP BLOOD AGAR
• Common Device Name: CULTURE MEDIA, NON-SELECTIVE AND NON-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: matt j. connor ; 7 loveton circle; sparks, MD 21152 ; 4103164000
• MDR Report Key: 22748009
• Report Number: 1119779-2025-02755
• Device Sequence Number: 20995558
• Product Code: JSG
• UDI-Device Identifier: 10382902217340
• UDI-Public: (01)10382902217340
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: K803025
• 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
• Report Date (Section B): 07/03/2025

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 Catalogue Number: 221734
• Device Lot Number: 3161027
• 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: 07/20/2023
• Initial Report FDA Received Date: 08/08/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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