MAUDE Adverse Event Report: BECTON DICKINSON & CO. (SPARKS) BD BBL¿ MUELLER HINTON II AGAR; CULTURE MEDIA, ANTIMICROBIAL SUSCEPTIBILITY TEST, MUELLER HINTON AGAR/BROTH

Catalog Number	211438
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	01/23/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
B3.The actual date of event is unknown.The date received by the manufacturer has been used for this field.There were multiple lot numbers reported to be involved.The information for each lot number is as follows: d4.Medical device lot #: 2293662 d4.Medical device expiration date: 31-aug-2026 d4.Unique identifier (udi) #: (b)(4) h4.Device manufacture date: 20-oct-2022.D4.Medical device lot #: 3304780 d4.Medical device expiration date: 31-aug-2027 d4.Unique identifier (udi) #: (b)(4) h4.Device manufacture date: 31-oct-2023.D4.Medical device lot #: 4142568 d4.Medical device expiration date: 29-feb-2028 d4.Unique identifier (udi) #: (b)(4) h4.Device manufacture date: 21-may-2024.A device evaluation is anticipated but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.
Event or Problem Description
It was reported while using bd bbl¿ mueller hinton ii agar that insufficient and heterogenous growth of an unspecified number of patient samples has been observed across multiple batches since july 2024.The customer prepared the dehydrated culture media by sterilizing the base, adding 100ml of horse blood, adding 900 ml of water, and adjusting the ph to 7.20±0.2.There was no health impact or consequence reported.
Additional Manufacturer Narrative
Investigation summary - this memo is to summarize findings on your complaint related to bottle mueller hinton ii agar 500g, catalog number 211438, batch#¿s 2277799,2293622,3304780, and 4142568 complaint #(b)(4) for performance.Components are milled and blended (where required) and dispensed into containers.Following qc release, and based upon inventory demand, final packaging operations occur, which include dispensing into and labeling of final configurations, followed by transport to the distribution center.The complaint investigation included a review of the batch history record.The batch history record review indicated no discrepancies.All release testing was satisfactory.Release testing includes powder appearance, solubility, prepared plate appearance, ph, and growth performance with organisms listed on the certificate of analysis.The complaint trends were reviewed for a period covering 12 months.During that time, there have been no other complaints about this product for the defect in question.No returns or photos were received.Mueller hinton ii agar is made, tested and regulated under clsi and iso standards for susceptibility testing of microorganisms to antimicrobial agents by disc diffusion technique.Bd makes no claims to growth of bordetella or addition of horse blood to prepared media.There have been no changes to the base formula, however, different lot numbers of raw materials can be used from batch to batch which can lead to slight variations in media appearance and/or performance.This complaint cannot be confirmed.Bd will continue to trend dcm complaints for this issue.
Event or Problem Description
It was reported while using bd bbl¿ mueller hinton ii agar that insufficient and heterogenous growth of an unspecified number of patient samples has been observed across multiple batches since (b)(6) 2024.The customer prepared the dehydrated culture media by sterilizing the base, adding 100ml of horse blood, adding 900 ml of water, and adjusting the ph to 7.20±0.2.There was no health impact or consequence reported.

• Brand Name: BD BBL¿ MUELLER HINTON II AGAR
• Common Device Name: CULTURE MEDIA, ANTIMICROBIAL SUSCEPTIBILITY TEST, MUELLER HINTON AGAR/BROTH
• 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: 21427239
• Report Number: 1119779-2025-00102
• Device Sequence Number: 18083532
• Product Code: JTZ
• UDI-Device Identifier: 00382902114383
• UDI-Public: (01)00382902114383(11)221004(17)260531(10)2277799
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• 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,Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/25/2025

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: 05/31/2026
• Device Catalogue Number: 211438
• Device Lot Number: 2277799
• 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: 01/23/2025
• Supplement Date Received by Manufacturer: 08/25/2025
• Initial Report FDA Received Date: 02/20/2025
• Supplement Report FDA Received Date: 08/26/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/04/2022
• 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