BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PLATE MUELLER HINTON AGAR 5% SB 20 EA

    MDR report key: 11653834 · Received April 12, 2021

    Report

    Report Number
    2243072-2021-01098
    Event Type
    Malfunction
    Date Received
    April 12, 2021
    Date of Event
    March 19, 2021
    Report Date
    April 7, 2021
    Manufacturer
    BECTON DICKINSON
    Product Code
    JTZ
    PMA / PMN Number
    PREAMENDMENT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    OEM MANUFACTURE: THE MANUFACTURING LOCATION FOR THIS PRODUCT IS (B)(4) . THIS SITE IS AN OEM MANUFACTURING SITE. THEREFORE, BD CORPORATE HEADQUARTERS IN (B)(4) HAS BEEN LISTED AND THE (B)(4) FDA REGISTRATION NUMBER HAS BEEN USED FOR THE MANUFACTURE REPORT NUMBER. INVESTIGATION SUMMARY: THE COMPLAINT WAS CONFIRMED AS THE REPORTED DEFECT ON A RETURNED SAMPLE . THE ISSUE WAS CONTAMINATION. NO ISSUE IN DHR. NO ISSUE IN RETENTION SAMPLE. ROOT CAUSE WAS UNDETERMINDED. NO TREND.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WHILE USING PLATE MUELLER HINTON AGAR 5% SB 20 EA CONTAMINATION WAS OBSERVED BY THE LABORATORY PERSONNEL. THERE WAS NO INDICATION THAT RESULTS WERE REPORTED OUT AND THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "THIS IS A REPORT ABOUT MOLD GROWTH ON THE MEDIA. ACCORDING TO THE CUSTOMER'S REPORT, MOLD GROWTH WAS FOUND ON THE MEDIA IN AN UNOPENED SLEEVE."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    550837 PLATE MUELLER HINTON AGAR 5% SB 20 EA CULTURE MEDIA, ANTIMICROBIAL SUSCEPTIBILITY TEST, MUELLER HINTON AGAR/BROTH JTZ BECTON DICKINSON 0338472

    Patients

    Seq Age Sex Outcome Treatment
    1