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

Model Number	212322
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	06/20/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H.3.A device evaluation and/or device history review is anticipated but is not complete.Upon completion, a supplemental report will be filed.
Event or Problem Description
It was reported that while using bd bbl¿ mueller hinton ii broth, cation-adjusted there was insufficient growth in two bottles.No patient impact reported.The following information was provided by the initial reporter: "bacteria don't grow well.".
Event or Problem Description
It was reported that while using bd bbl¿ mueller hinton ii broth, cation-adjusted there was insufficient growth in two bottles.No patient impact reported.The following information was provided by the initial reporter: "bacteria don't grow well.".
Additional Manufacturer Narrative
H.6.Investigation summary: 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 records.The batch history record review indicated no discrepancies.All release testing was satisfactory for both lots.Release testing includes dehydrated medium appearance, solution appearance, ph, and biological performance with organisms as specified on the bd certificate of analysis.The complaint trends were reviewed for a period covering 12 months.During that time, there have been no confirmed complaints on this product for the defect in question.A similar complaint was raised by this customer in december 2022.No returns or photos were received.The customer complaint states that they are having problems growing strains of microorganisms (acinetobacter, klebsiella, e.Coli) and that strains are no longer meeting their known optical densities.After multiple attempts, no further details were received regarding the customer¿s preparation or application of this media.We are unable to replicate the customer¿s application and no further investigation can be performed.From the information provided by the customer, this complaint cannot be confirmed.H3 other text : see h.10.

• Brand Name: BD BBL¿ MUELLER HINTON II BROTH, CATION-ADJUSTED
• 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: jennifer suh ; 5859 farinon drive; san antonio, TX 78249 ; 8448235433
• MDR Report Key: 17332663
• Report Number: 1119779-2023-00778
• Device Sequence Number: 6573715
• Product Code: JTZ
• UDI-Device Identifier: 00382902123224
• UDI-Public: 00382902123224
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• PMA/510(K) Number: PREAMENDMENT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,User Facility
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 09/23/2023

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: 07/31/2026
• Device Model Number: 212322
• Device Catalogue Number: 212322
• Device Lot Number: 2343309
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/20/2023
• Supplement Date Received by Manufacturer: 09/23/2023
• Initial Report FDA Received Date: 07/17/2023
• Supplement Report FDA Received Date: 09/28/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 12/09/2022
• Is the Device Labeled for Single Use? (Y/N): No
• 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