BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MESA LABORATORY PH BUFFER SOLUTION, PINT

    MDR report key: 3622056 · Received January 24, 2014

    Report

    Report Number
    3622056
    Event Type
    Malfunction
    Date Received
    January 24, 2014
    Date of Event
    October 1, 2013
    Report Date
    October 3, 2013
    Manufacturer
    MESA LABORATORIES
    Product Code
    JCC
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MI, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    WE HAVE LEARNED OF A POTENTIAL MOLD CONTAMINATION OF MESA LABORATORIES 7.0 PH BUFFER SOLUTION USED IN THIS FACILITY. ALL AFFECTED LOT NUMBERS PULLED. AT THIS TIME, WE ARE NOT AWARE OF ANY ADVERSE EVENTS ASSOCIATED WITH THIS PROBLEM, HOWEVER, WE WANT TO ALERT BOTH MESA LABORATORIES AND THE FDA THE ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    57184 MESA LABORATORY PH BUFFER SOLUTION, PINT NONE JCC MESA LABORATORIES ML-PL-1158
    57246 MESA LABORATORY PH BUFFER SOLUTION, QUART NONE JCC MESA LABORATORIES ML-PL-1158

    Patients

    Seq Age Sex Outcome Treatment
    1 Other