BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MESA LABORATORIES PH 7.0 BUFFER SOLUTION PT BTL

    MDR report key: 3607965 · Received January 24, 2014

    Report

    Report Number
    3607965
    Event Type
    Malfunction
    Date Received
    January 24, 2014
    Date of Event
    September 30, 2013
    Report Date
    October 3, 2013
    Manufacturer
    MESA LABORATORIES
    Product Code
    JCC
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    WI, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    WE HAVE LEARNED OF A POTENTIAL MOLD CONTAMINATION OF (B)(4) LABORATORIES 7.0 PH BUFFER SOLUTION THAT IS USED AT THIS FACILITY. AT THIS TIME, WE ARE NOT AWARE OF AN ADVERSE EVENTS ASSOCIATED WITH THIS PROBLEM; HOWEVER, WE WANT TO ALERT BOTH (B)(4) LABORATORIES AND THE FDA OF THIS ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    55604 MESA LABORATORIES PH 7.0 BUFFER SOLUTION PT BTL NONE JCC MESA LABORATORIES ML-P7-1158
    55605 MESA LABORATORIES PH 7.0 BUFFER SOLUTION QRT BTL NONE JCC MESA LABORATORIES ML-P7-1158

    Patients

    Seq Age Sex Outcome Treatment
    1 Other