BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MESA LABORATORIES PH 7.0 BUFFER SOLUTION PINT BTL

    MDR report key: 3622030 · Received January 24, 2014

    Report

    Report Number
    3622030
    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
    MA, 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 THAT IS USED AT THIS FACILITY. 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. PRODUCT USE WAS DISCONTINUED UPON NOTICE OF THE POSSIBLE MOLD ISSUE ON OR AROUND (B)(6) 2013.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    57043 MESA LABORATORIES PH 7.0 BUFFER SOLUTION PINT BTL NONE JCC MESA LABORATORIES ML-P7-1158
    57044 MESA LABORATORIES PH 7.0 BUFFER SOLUTION QUART BTL NONE JCC MESA LABORATORIES ML-P7-1158

    Patients

    Seq Age Sex Outcome Treatment
    1 Other