BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD BBL¿ MUELLER HINTON II AGAR

    MDR report key: 13654756 · Received March 2, 2022

    Report

    Report Number
    1119779-2022-00334
    Event Type
    Malfunction
    Date Received
    March 2, 2022
    Date of Event
    November 5, 2021
    Report Date
    March 18, 2022
    Manufacturer
    BECTON, DICKINSON & CO. (SPARKS)
    Product Code
    JTZ
    UDI-DI
    00382902114383
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PE
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THERE IS NO 510(K) FOR THIS DEVICE AS IT IS PRE-AMENDMENT. A SAMPLE IS AVAILABLE FOR EVALUATION. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Additional Manufacturer Narrative · 0

    H6: INVESTIGATION SUMMARY: THIS RESPONSE IS TO SUMMARIZE FINDINGS ON YOUR COMPLAINT RELATED TO BOTTLE MUELLER HINTON II AGAR 500G, CATALOG NUMBER 211438, BATCH 1131296, COMPLAINT #(B)(4) FOR UNSATISFACTORY PRODUCT LABELING. 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. WHERE THE FINAL PACKAGING CONFIGURATION IS TERMINALLY IRRADIATED, PACKAGED PRODUCT IS SENT TO THE IRRADIATOR, THEN QC RELEASED PRIOR TO ENTRY INTO INVENTORY. THE COMPLAINT INVESTIGATION INCLUDED A REVIEW OF THE BATCH HISTORY RECORD (BHR) FOR BOTTLE MUELLER HINTON II AGAR 500G, BATCH 1131296. 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 LOT FOR ANY DEFECTS. TWO PHOTOS WERE RECEIVED THAT BOTH PICTURED BOTTLES OF 211438, LOT 1131296 WITH PORTIONS OF THE VENDOR-PRINTED LABELING NOT PRINTED. THIS COMPLAINT HAS BEEN CONFIRMED FROM THE CUSTOMER PHOTOS. OPERATORS ARE RESPONSIBLE FOR ENSURING BOTTLES ARE APPROPRIATELY LABELS WHEN MATERIAL IS COLLECTED FROM THE ACCUMULATION TABLE AND PLACED INTO SHELF-BOXES. THE MISSING FIELDS SHOWN IN THE LABEL ARE PRE-PRINTED BY BD¿S LABEL SUPPLIER, AND BATCH SPECIFIC INFORMATION (BLACK INK) IS PRINTED IN-HOUSE. ALL LABELS AFFIXED TO THE BATCH HISTORY RECORD WERE SATISFACTORY. NO ROOT CAUSE HAS BEEN IDENTIFIED FOR WHY THE INFORMATION WAS NOT PRINTED BY BD'S LABEL SUPPLIER. THE CUSTOMER¿S DEFECT HAS BEEN PRESENTED DURING PACKAGING MANUFACTURING MEETINGS FOR AWARENESS. NO CORRECTIVE ACTIONS ARE SLATED AT THIS TIME. BD WILL CONTINUE TO MONITOR DCM COMPLAINTS FOR LABELING DEFECTS.

    Description of Event or Problem · 0

    IT WAS REPORTED WHILE TESTING WITH BD BBL¿ MUELLER HINTON II AGAR TWO LABEL WERE FOUND TO BE ILLEGIBLE. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: ON NOVEMBER 25, THE SUPROM CLIENT NOTIFIED A COMPLAINT, ABOUT THE RECEPTION OF THE PRODUCT WITH THE ILLEGIBLE LABEL, CATALOG: 211438, LOT: 1131296, 02 BOTTLES.

    Description of Event or Problem · 0

    IT WAS REPORTED WHILE TESTING WITH BD BBL¿ MUELLER HINTON II AGAR TWO LABEL WERE FOUND TO BE ILLEGIBLE. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: ON (B)(6) 2022, THE SUPROM CLIENT NOTIFIED A COMPLAINT, ABOUT THE RECEPTION OF THE PRODUCT WITH THE ILLEGIBLE LABEL. CATALOG: 211438. LOT: 1131296. (B)(4) BOTTLES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    281318 BD BBL¿ MUELLER HINTON II AGAR CULTURE MEDIUM FOR ANTIMICROBIAL SUSCEPTIBILITY TESTS. JTZ BECTON, DICKINSON & CO. (SPARKS) 211438 1131296 00382902114383

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown