MAUDE Adverse Event Report: BECTON, DICKINSON & CO. (Sparks) BD BBL¿ Chocolate II Agar (GC II Agar with Hemoglobin and IsoVitaleX¿); CULTURE MEDIA, ENRICHED

Catalog Number	221267
Medical Device Problem Codes	Contamination (1120); Incorrect, Inadequate or Imprecise Result or Readings (1535)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/06/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that while using bd bbl¿ chocolate ii agar (gc ii agar with hemoglobin and isovitalex¿), the customer observed mold/fungal contamination on an unspecified number of plates following inoculation.No adverse health impact, patient harm, or other consequences were reported.
Additional Manufacturer Narrative
A device evaluation and/or device history review is anticipated but is not complete.Upon completion, a supplemental report will be filed.

• Brand Name: BD BBL¿ Chocolate II Agar (GC II Agar with Hemoglobin and IsoVitaleX¿)
• Common Device Name: CULTURE MEDIA, ENRICHED
• 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 ; +1(410)316-4000
• MDR Report Key: 50616639
• Report Number: 1119779-2026-01870
• Device Sequence Number: 10657315
• Product Code: KZI
• UDI-Device Identifier: 10382902212673
• UDI-Public: (01)10382902212673(17)260907(10)6125328
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• 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,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 08/24/2026

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: 09/07/2026
• Device Catalogue Number: 221267
• Device Lot Number: 6125328
• 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: Not provided
• Initial Report FDA Received Date: 09/04/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/20/2026
• 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