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

Model Number	212257
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	08/11/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported by the customer uses product to produce agar in petri dishes to analyse antibiotic resistance.Bd bbl¿ mueller hinton ii agar.Repeat testing was performed.No patient impact was reported.The following information was provided by the initial reporter: product does not meet eucast specifications especially when using ampicilli, i.E.Very small inhibition area leading to production stop.Other antibiotics also show smaller inhibition areas.- in addition to various other antibiotics, the inhibitory yard is permanently too small, especially in ampicillin.
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
H.6 investigation summary: this memo is to summarize findings on complaint related to pail mueller hinton ii agar 25lb, catalog number 212257, batch 2046733, and complaint #5794043 for unsatisfactory performance, antibiotic inhibition.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 confirmed complaints on this product for the defect in question.No returns or photos were received.A retention sample of the complaint batch of mueller hinton ii agar was tested per the kirby-bauer method of antimicrobial susceptibility for escherichia coli and gentamycin (gm-10) per current clsi standards, to show whether the smaller zone sizes were evident.The sample was prepared according to label instructions.The flask was mixed well to dissolved, then heated with frequent agitation and boiled for one minute.The media was autoclaved at 121°c for 15 minutes and allowed to cool to 45-50°c in a waterbath.Plates were poured.Plates were inoculated with escherichia coli atcc 25922 and triplicate discs of gm-10 were applied using a sensi-disc dispenser.Plates were incubated at 33-37°c for 16-18 hours.Expected recovery is confluent lawn of growth and zone sizes of 19 to 26 mm for gm-10 should be obtained.A confluent lawn of e.Coli growth was obtained on the plates.Zones were measured using calibrated calipers.All zones were within range at 23.94mm, 23.73mm and 23.23mm.The mean zone sizes from lot 2046733 release testing results of escherichia coli, atcc 25922 and pseudomonas aeruginosa, atcc 27853 and for those antibiotics/concentrations tested by bd are reported below.Specification: mean zone size (mm): atcc 25922, sxt, cip-5ug, 23-29, 30-40, 27.2, 33.3, atcc 27853, atm-30ug, gm-10ug, imp-10ug cip-5ug, 23-29, 17-23, 20-28, 25-33, 26.6, 21.9, 22.1, 28.1.Bd does not maintain zone size data for e.Faecalis atcc 29212, ampicillin am-2ug or s.Aureus atcc 29213 with am-2 ug, sxt-1.25ug/23.75ug, or va-5ug as they are not part of the release battery for this product.Bd was not able to confirm the smaller zone size defect described by the customer.This complaint cannot be confirmed.Bd will continue to trend dcm complaints for performance defects.H3 other text : see h.10.
Event or Problem Description
It was reported by the customer uses product to produce agar in petri dishes to analyse antibiotic resistance.Bd bbl¿ mueller hinton ii agar.Repeat testing was performed.No patient impact was reported.The following information was provided by the initial reporter: product does not meet eucast specifications especially when using ampicilli, i.E.Very small inhibition area leading to production stop.Other antibiotics also show smaller inhibition areas.In addition to various other antibiotics, the inhibitory yard is permanently too small, especially in ampicillin.

• 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: phillip emmert ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 15218474
• Report Number: 1119779-2022-01097
• Device Sequence Number: 5887454
• Product Code: JTZ
• UDI-Device Identifier: 00382902122579
• UDI-Public: 00382902122579
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• 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: Foreign,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/17/2022

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: 01/31/2026
• Device Model Number: 212257
• Device Catalogue Number: 212257
• Device Lot Number: 2046733
• 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: 08/10/2022
• Supplement Date Received by Manufacturer: 10/17/2022
• Initial Report FDA Received Date: 08/12/2022
• Supplement Report FDA Received Date: 10/19/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/15/2022
• 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