BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PLATE MACCONKEY AGAR 100MM 10EA

    MDR report key: 14289537 · Received May 5, 2022

    Report

    Report Number
    9614033-2022-00035
    Event Type
    Malfunction
    Date Received
    May 5, 2022
    Date of Event
    April 7, 2022
    Report Date
    July 29, 2022
    Manufacturer
    BECTON DICKINSON DE MEXICO
    Product Code
    JSI
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MX
    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 MANUFACTURED OUTSIDE THE US AND NOT SOLD IN THE US BUT IS CONSIDERED TO BE SUBSTANTIALLY SIMILAR TO THE LEGALLY U.S. MARKETED DEVICE BD BBL¿ MACCONKEY II AGAR CATALOG NUMBER 221172 WHICH IS A CLASS 1, EXEMPT DEVICE. 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

    H.6 INVESTIGATION SUMMARY: THE NOTIFIED BATCH FILE WAS REVIEWED, VERIFYING THAT ALL THE PROCESSES WERE FOLLOWED EFFECTIVELY DURING THE MANUFACTURE OF THE PRODUCT, LIKEWISE THE BATCH WAS ANALYZED BY THE QUALITY CONTROL DEPARTMENT AND THE RESULTS WERE SATISFACTORY FOR THE RELEASE OF THE BATCH. IT WAS NOT POSSIBLE TO CARRY OUT THE REVISION OF THE RETENTION SAMPLES BECAUSE THEY HAD ALREADY FULFILLED THEIR LIFE TIME, SO THEY WERE PURGED. IT IS CONCLUDED THAT THE EVENT REPORTED BY THE CLIENT IS CLASSIFIED AS CONFIRMED BASED ON THE PHOTOGRAPHIC EVIDENCE PROVIDED BY THE CLIENT, HOWEVER, A ROOT CAUSE ATTRIBUTABLE TO A FAILURE IN ANY OF THE PROCESS CONTROLS DURING THE PRODUCTION OR STORAGE PROCESS WAS NOT IDENTIFIED. WHILE THE PRODUCT WAS KEPT UNDER THE PROTECTION OF BD. THE PRODUCT ACCEPTS AN AQL OF 2.5, SO TWO CONTAMINATED PLATES IS ACCEPTABLE WITHIN THE SPECIFICATION CRITERIA. IT IS WORTH MENTIONING THAT THE PRODUCT WAS FOR 154 DAYS OUTSIDE THE BD SHELTER.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT PRIOR TO USE WITH THE PLATE MACCONKEY AGAR 100MM 10EA, PLATES WERE CONTAMINATED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CLIENT SENDS THE FOLLOWING COMPLAINT ABOUT THE MAC CONKEY AGAR PLATE, LOT: 1288823, CA: (B)(6) 2022; DUE TO THE PRESENCE OF CONTAMINATION IN THEM.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT PRIOR TO USE WITH THE PLATE MACCONKEY AGAR 100MM 10EA, PLATES WERE CONTAMINATED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "CLIENT SENDS THE FOLLOWING COMPLAINT ABOUT THE MAC CONKEY AGAR PLATE, LOT: 1288823, CA: 05/12/22; DUE TO THE PRESENCE OF CONTAMINATION IN THEM."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1379863 PLATE MACCONKEY AGAR 100MM 10EA CULTURE MEDIA, SELECTIVE AND DIFFERENTIAL JSI BECTON DICKINSON DE MEXICO 1288823

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown