BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD BBL¿ MUELLER HINTON II AGAR

    MDR report key: 21427239 · Received February 20, 2025

    Report

    Report Number
    1119779-2025-00102
    Event Type
    Malfunction
    Date Received
    February 20, 2025
    Date of Event
    January 23, 2025
    Report Date
    August 25, 2025
    Manufacturer
    BECTON DICKINSON & CO. (SPARKS)
    Product Code
    JTZ
    UDI-DI
    00382902114383
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    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.

    Additional Manufacturer Narrative · 0

    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.

    Description of Event or Problem · 0

    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.

    Description of Event or Problem · 0

    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.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    417156 BD BBL¿ MUELLER HINTON II AGAR CULTURE MEDIA, ANTIMICROBIAL SUSCEPTIBILITY TEST, MUELLER HINTON AGAR/BROTH JTZ BECTON DICKINSON & CO. (SPARKS) 2277799 00382902114383

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown