BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARBON DIOXIDE USP

    MDR report key: 9348256 · Received November 19, 2019

    Report

    Report Number
    MW5091177
    Event Type
    Malfunction
    Date Received
    November 19, 2019
    Date of Event
    November 15, 2019
    Report Date
    November 15, 2019
    Manufacturer
    NORCO INC.
    Product Code
    BXK
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CA, US
    Reporter Occupation
    SERVICE PERSONNEL

    Narratives

    Description of Event or Problem · 1

    I WORK A (B)(6) IN (B)(6). WE RECEIVED USP CARBON DIOXIDE AT MY FACILITY FROM NORCO BASED OUT OF (B)(6). THESE CYLINDERS HAD MULTIPLE ISSUES, INCLUDING MULTIPLE BATCH. LOT NUMBERS BELONGING TO AIRGAS AND MATHESON AND TRIGAS AS WELL AS OTHER MEDICAL SUPPLY COMPANY LABELS. IMPROPER MARKING AND LABELING AT MEDICAL GASES IN A SEVERE ISSUE, WHICH COULD TURN DEADLY. FDA SAFETY REPORT ID# (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1137217 CARBON DIOXIDE USP GAS, CALIBRATION, SPECIFIED CONCENTRATION BXK NORCO INC. E SIZE

    Patients

    Seq Age Sex Outcome Treatment
    1