BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD DIFCO¿ MUELLER HINTON AGAR

    MDR report key: 17671273 · Received September 1, 2023

    Report

    Report Number
    1119779-2023-00966
    Event Type
    Malfunction
    Date Received
    September 1, 2023
    Date of Event
    August 10, 2023
    Report Date
    October 25, 2023
    Manufacturer
    BECTON, DICKINSON & CO. (SPARKS)
    Product Code
    JTZ
    UDI-DI
    00382902252504
    PMA / PMN Number
    PREAMENDMENT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H.6 INVESTIGATION SUMMARY: THE COMPLAINT INVESTIGATION INCLUDED A REVIEW OF THE BATCH HISTORY RECORD (BHR) FOR BOTTLE MUELLER HINTON AGAR 500G, BATCH 2060506. ALL QC RELEASE TESTING INCLUDING DEHYDRATED MEDIUM APPEARANCE, SOLUBILITY, PREPARED PLATE APPEARANCE, PH, AND CULTURAL RESPONSE WITH THOSE ORGANISMS SPECIFIED ON THE BD CERTIFICATE OF ANALYSIS WAS SATISFACTORY. COMPLAINT TRENDS WERE REVIEWED FOR A PERIOD COVERING 12 MONTHS. DURING THAT TIME, THERE HAVE BEEN NO OTHER COMPLAINTS RECEIVED ON THIS PRODUCT FOR ANY DEFECTS. NO PHOTOS OR RETURNS WERE RECEIVED OR REQUIRED FOR INVESTIGATION. THE CUSTOMER STATED THAT THEY RECEIVED MATERIAL (B)(4), LOT 2060506 WITHOUT A CE MARK AS EXPECTED. THE CE MARK IS REQUIRED FOR THOSE PRODUCTS AS DETERMINED BY THE DEVICE CLASSIFICATION; DEVICES THAT ARE MARKETED AS MEDICAL DEVICES AND MAINTAIN IVD CLAIMS PER EU IVDR WOULD REQUIRE THIS SYMBOL ON THE PRODUCT LABELING. BOTTLE MUELLER HINTON AGAR, 225250 IS LABELED "FOR LABORATORY USE" AND IS NOT INTENDED TO BE USED FOR IVD PURPOSES. BD CONTINUALLY MONITORS PRODUCTS THROUGHOUT THE PRODUCT LIFECYCLE TO ENSURE THAT THEY ARE PROPERLY CLASSIFIED. THIS COMPLAINT CANNOT BE CONFIRMED.

    Additional Manufacturer Narrative · 0

    B3: DATE OF EVENT IS UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. E.6 INITIAL REPORTER E-MAIL: (B)(6). H.3. A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHILE USING BD DIFCO¿ MUELLER HINTON AGAR THAT THERE WAS THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER THAT THERE WAS NO LABEL OR MISSING LABEL INFORMATION. 'WE RECEIVED BD MUELLER HINTON REF. 225250 BUT IT ISN¿T CE MARKED AS EXPECTED? THE LABEL MENTIONS ¿FOR LAB USE ONLY¿ BUT FOR HUMAN CLINICAL IT WOULD NEED TO BE CE MARKED. I THOUGHT THAT I WOULD RECEIVE PRODUCT WITH THE NEW LABEL WHICH IS MULTI FOLDED TO ALLOW THEM TO HAVE ALL EUROPEAN LANGUAGES INCLUDING PREPARATION INSTRUCTIONS."

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHILE USING BD DIFCO¿ MUELLER HINTON AGAR THAT THERE WAS THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER THAT THERE WAS NO LABEL OR MISSING LABEL INFORMATION. 'WE RECEIVED BD MUELLER HINTON REF. (B)(4) BUT IT ISN¿T CE MARKED AS EXPECTED? THE LABEL MENTIONS ¿FOR LAB USE ONLY¿ BUT FOR HUMAN CLINICAL IT WOULD NEED TO BE CE MARKED. I THOUGHT THAT I WOULD RECEIVE PRODUCT WITH THE NEW LABEL WHICH IS MULTI FOLDED TO ALLOW THEM TO HAVE ALL EUROPEAN LANGUAGES INCLUDING PREPARATION INSTRUCTIONS."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1438900 BD DIFCO¿ MUELLER HINTON AGAR CULTURE MEDIA, ANTIMICROBIAL SUSCEPTIBILITY TEST, MUELLER HINTON AGAR/BROTH JTZ BECTON, DICKINSON & CO. (SPARKS) 2060506 00382902252504

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown