MAUDE Adverse Event Report: BECTON, DICKINSON AND COMPANY BD BBL CHROMAGAR MRSA II; CULTURE MEDIA, ANTIMICROBIAL SUSCEPTIBILITY TEST, EXCLUDING MUELLER HINTON AGAR

Model Number	215229
Health Effect - Clinical Code	Drug Resistant Bacterial Infection (4553)
Date of Event	05/26/2025
Type of Reportable Event	Malfunction
Event or Problem Description
On [date redacted], the routine weekly methicillin resistant staph aureus (mrsa) surveillance screening was conducted in the neonatal intensive care unit (nicu).Additional surveillance swabbing was also conducted in the special care nurseries (scn).Following this screening/swabbing in these specific units, ten (10) new cases of suspected nosocomial mrsa infections were identified in these units.The volume of positive results was highly unusual and raised an alert for further investigation and analysis.A thorough epidemiological review was conducted as well as genome sequencing of the isolates.The ten (10) patients were re-swabbed and two (2) resulted as positive but eight (8) resulted as negative for mrsa and positive for mssa [methicillin-susceptible staphylococcus aureus].Genome sequencing of the original isolates identified phenotypic ast-7 mssa confirming no relatedness between the cases.The mrsa media was determined to be faulty.This initial finding led to a more extensive review led by the infectious disease and infection control teams of the use of the media throughout the hospital.It has been determined that this event spanned from [date redacted]-[date redacted], approximately three weeks.As mentioned above, the original isolates identified phenotypic ast-7 mssa.A comprehensive investigation was conducted, and the mrsa media was determined to be faulty.The initial quality control (qc) was not problematic.The manufacturer was notified.The qc was repeated and passed.[redacted] infectious disease, [redacted] microbiology, and [redacted] pathology departments collaborated with the [redacted] patient safety and patient and family relations (pfr) departments to conduct a collaborative case review process to identify the contributing factors and determine potential corrective actions.A comprehensive chart review was completed.In summary: 85 patients were affected.Out of these 85 patients, 7 patients were deceased.Chart review was performed on all of the deceased patients and there was no strong link between the deaths of these patients and the affected media or mrsa results.8 patients were discharged to external healthcare facilities and three required rescreening.17 patients were still inpatient during the review period and five required rescreening.53 of the patients were outpatients in which the primary care providers (pcp) were notified of the potential false positive result via email or fax, or the discharge attending was notified via email if the patient did not have a pcp or the non-[redacted] pcp could not be reached by the contact info provided in epic.There is potential that some patients may have received vancomycin unnecessarily, however no harm has been identified/confirmed.The office of the chief medical officer (ocmo) was notified of the issue early on in case this was a multi-site [redacted] issue, which later was determined to be limited to only [redacted].There is no more of this lot left as it has all been used.Manufacturer response for culture media, antimicrobial susceptibility test, excluding mueller hinton agar, bd bbl¿ chromagar® mrsa ii (per site reporter).No response yet.

• Brand Name: BD BBL CHROMAGAR MRSA II
• Common Device Name: CULTURE MEDIA, ANTIMICROBIAL SUSCEPTIBILITY TEST, EXCLUDING MUELLER HINTON AGAR
• Manufacturer (Section D): BECTON, DICKINSON AND COMPANY; 1 becton dr; franklin lakes NJ 07417
• MDR Report Key: 22467332
• Report Number: 22467332
• Device Sequence Number: 7986153
• Product Code: JSO
• UDI-Device Identifier: 30382902152294
• UDI-Public: (01)30382902152294
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date (Section B): 07/09/2025
• Report Date (Section F): 07/09/2025

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
• Device Model Number: 215229
• Device Catalogue Number: 215229
• Device Lot Number: 5136583
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 07/10/2025
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 07/10/2025
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Male
• Date Report Sent to FDA: 07/09/2025