BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MESA LABORATORIES PH 7.0 BUFFER SOLUTION PINT

    MDR report key: 3608801 · Received January 24, 2014

    Report

    Report Number
    3608801
    Event Type
    Malfunction
    Date Received
    January 24, 2014
    Date of Event
    October 1, 2013
    Report Date
    October 7, 2013
    Manufacturer
    MESA LABORATORIES
    Product Code
    JCC
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    IL, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    WE HAVE LEARNED OF POTENTIAL MOLD CONTAMINATION OF (B)(4) LABORATORIES 7.0 PH BUFFER SOLUTION THAT IS USED AT THIS FACILITY. AT THIS TIME THERE HAVE BEEN NO REPORTED PATIENT EVENTS. HOWEVER, AFTER INSPECTION THE PRODUCT WAS PULLED ON 09/25/2013.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    56138 MESA LABORATORIES PH 7.0 BUFFER SOLUTION PINT MESA LABORATORIES PH 7.0 BUFFER SOLUTION PINT JCC MESA LABORATORIES ML-P7-1178
    56139 MESA LABORATORIES PH 7.0 BUFFER SOLUTION QUART MESA LABORATORIES PH 7.0 BUFFER SOLUTION QUART JCC MESA LABORATORIES

    Patients

    Seq Age Sex Outcome Treatment
    1 Other