MAUDE Adverse Event Report: BECTON DICKINSON & CO. (SPARKS) BD BBL¿ CHROMAGAR® MRSA II; CULTURE MEDIA, ANTIMICROBIAL SUSCEPTIBILITY TEST

Catalog Number	215229
Medical Device Problem Code	Incorrect, Inadequate or Imprecise Result or Readings (1535)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/11/2025
Type of Reportable Event	Malfunction
Event or Problem Description
Report 24 of 40.It was reported while using bd bbl¿ chromagar® mrsa ii, there were pink/purple colonies for mrsa growth.When the testing was repeated the results were negative.There was no health impact or consequence reported.
Additional Manufacturer Narrative
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 215229, 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 for batch 5093285 was satisfactory and no quality notifications were generated during manufacturing and inspection.All performance testing on this batch was satisfactory at the time of release.All batches are tested prior to release and results reported on the certificate of analysis which can be obtained at www.Bd.Com/regdocs.Plate chromagar mrsa ii is stability tested biennially for biological performance to ensure performance is satisfactory throughout shelf life with the organisms that are reported on the certificate of analysis.No photos or returns were received for investigation.Retention samples were visually inspected, and no bubbles/ pits were observed.Retention samples were tested per the standard performance procedure which is also described in the ifu (instructions for use, available on bd.Com/e-labeling).Testing conducted for the investigation has replicated the performance defect.This complaint is confirmed for failure to inhibit and unconfirmed for bubbles.No trends were observed for bubbles.A trend in performance complaints has been identified for batch 5093285.Bd has initiated a capa (corrective and preventative action) to formally investigate the performance issue identified for batch 5093285.Bd will continue to trend complaints for performance.
Event or Problem Description
Report 24 of 40.It was reported while using bd bbl¿ chromagar® mrsa ii, there were pink/purple colonies for mrsa growth.When the testing was repeated the results were negative.There was no health impact or consequence reported.

• Brand Name: BD BBL¿ CHROMAGAR® MRSA II
• Common Device Name: CULTURE MEDIA, ANTIMICROBIAL SUSCEPTIBILITY TEST
• 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: 22338394
• Report Number: 1119779-2025-00719
• Device Sequence Number: 13043140
• Product Code: JSO
• UDI-Device Identifier: 10382902152290
• UDI-Public: (01)10382902152290(11)250403(17)250623(10)5093285
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K092767
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/02/2025

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: 06/23/2025
• Device Catalogue Number: 215229
• Device Lot Number: 5093285
• 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: 06/16/2025
• Supplement Date Received by Manufacturer: 10/02/2025
• Initial Report FDA Received Date: 06/26/2025
• Supplement Report FDA Received Date: 10/24/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/03/2025
• 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