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

Catalog Number	221267
Medical Device Problem Code	Device Markings/Labelling Problem (2911)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/18/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported prior to using bd bbl¿ chocolate ii agar that three (3) sleeves of media were missing the product label.There was no health impact or consequence reported.
Additional Manufacturer Narrative
E1.Initial reporter address:(b)(6).A device evaluation is anticipated but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.
Additional Manufacturer Narrative
Investigation summary: 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 review was satisfactory, and no quality notifications were generated during manufacturing and inspection.The release testing that is performed on this batch included an inspection quality defect for missing sleeve labels.The complaint history was reviewed, and no other complaints have been taken on batch 4345757.Retention samples from batch 4345757 were not available for inspection.Two photos were available for investigation of this complaint.One photo showed three sleeves of chocolate plates without labels and no plate information visible.One photo showed one partial sleeve of red plates atop a carton.This complaint can be confirmed for missing sleeve label.No complaint trends have been identified for this product; no actions are indicated at this time.Bd will continue to trend complaints for missing labels.
Event or Problem Description
It was reported prior to using bd bbl¿ chocolate ii agar that three (3) sleeves of media were missing the product label.There was no health impact or consequence reported.

• Brand Name: BD BBL¿ CHOCOLATE II AGAR
• 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: matt j. connor ; 7 loveton circle; sparks, MD 21152 ; 4103164000
• MDR Report Key: 21652364
• Report Number: 1119779-2025-00203
• Device Sequence Number: 17998176
• Product Code: JTY
• UDI-Device Identifier: 10382902212673
• UDI-Public: (01)10382902212673(11)241210(17)250412(10)4345757
• 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,Distributor
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/28/2025

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 Expiration Date: 04/12/2025
• Device Catalogue Number: 221267
• Device Lot Number: 4345757
• 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: 02/20/2025
• Supplement Date Received by Manufacturer: 04/28/2025
• Initial Report FDA Received Date: 03/20/2025
• Supplement Report FDA Received Date: 05/06/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/10/2024
• 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