BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD BBL¿ CHROMAGAR¿ ORIENTATION AGAR

    MDR report key: 14518363 · Received May 26, 2022

    Report

    Report Number
    9614033-2022-00043
    Event Type
    Malfunction
    Date Received
    May 26, 2022
    Date of Event
    December 3, 2021
    Report Date
    July 12, 2022
    Manufacturer
    BECTON DICKINSON DE MEXICO
    Product Code
    JSH
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MX
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    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 CONTROLS IN THE PROCESSES 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 A SINGLE CONTAMINATED PLATE IS ACCEPTABLE WITHIN THE SPECIFICATION CRITERIA. IT IS WORTH MENTIONING THAT THE PRODUCT WAS FOR 5 DAYS OUTSIDE THE BD SHELTER.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD BBL¿ CHROMAGAR¿ ORIENTATION AGAR WAS CONTAMINATED. THERE WAS NO REPORT OF ADVERSE USER OR PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM SPANISH: THE MATERIAL HAS A STAIN. (B)(6) 2022/PW - ISSUE IS CONTAMINATION BASED ON PHOTO REVIEW - VERIFIED BY QE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD BBL¿ CHROMAGAR¿ ORIENTATION AGAR WAS CONTAMINATED. THERE WAS NO REPORT OF ADVERSE USER OR PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM SPANISH: "THE MATERIAL HAS A STAIN" "(B)(6) 2022/PW - ISSUE IS CONTAMINATION BASED ON PHOTO REVIEW - VERIFIED BY QE".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2763451 BD BBL¿ CHROMAGAR¿ ORIENTATION AGAR CULTURE MEDIA, NON-SELECTIVE AND DIFFERENTIAL JSH BECTON DICKINSON DE MEXICO 1308077

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown