BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MEMBERS MARK

    MDR report key: 11774473 · Received May 4, 2021

    Report

    Report Number
    3005798905-2021-03005
    Event Type
    Malfunction
    Date Received
    May 4, 2021
    Date of Event
    April 30, 2021
    Report Date
    April 30, 2021
    Manufacturer
    MHC MEDICAL PRODUCTS, LLC
    Product Code
    FMF
    PMA / PMN Number
    K102178
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    LOT NUMBER 51391 PRODUCTION RECORD WERE INVESTIGATED. THE GRADUATION LINES SAMPLING PERFORMATION TEST SHOWED NO INDICATION OF ABNORMALITY AT TIME OF PRODUCTION.

    Additional Manufacturer Narrative · 0

    RETAINED LOT NUMBER 51391 WAS INSPECTED FOR PRINTING SCALE ANALYSIS TO FIND THAT DUE TO HUMAN ERROR THE FINAL CHECK OF THE SYRINGES CANNOT BE COMPLETELY ELIMINATED. DUE TO DEFECTS, TRAINING AND EQUIPMENT WILL BE CHANGED TO IMPROVE QUALITY OF SYRINGES.

    Description of Event or Problem · 0

    END USER REPORTS THAT THE UNITS MARKED ON A BARREL OF ONE SYRINGE IN A BOX OF ONE HUNDRED ARE DIFFICULT TO READ. THIS CAUSED COMPLICATION IN INSULIN DOSAGE.

    Description of Event or Problem · 0

    END USER REPORTS THAT THE UNITS MARKED ON A BARREL OF ONE SYRINGE IN A BOX OF ONE HUNDRED ARE DIFFICULT TO READ. THIS CAUSED COMPLICATION IN INSULIN DOSAGE.

    Additional Manufacturer Narrative · 1

    WHEN INITIAL TREND ANALYSIS FOR LOT NUMBER 51391 WAS CONDUCTED THERE WERE NO OTHER COMPLAINTS FOR LOT NUMBER 51391. ADDITIONAL INVESTIGATION WILL BE CONDUCTED FOR ROOT CAUSE OF COMPLAINT.

    Description of Event or Problem · 1

    END USER REPORTS THAT THE UNITS MARKED ON A BARREL OF ONE SYRINGE IN A BOX OF ONE HUNDRED ARE DIFFICULT TO READ. THIS CAUSED COMPLICATION IN INSULIN DOSAGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    670327 MEMBERS MARK SYRINGE FMF MHC MEDICAL PRODUCTS, LLC 51391

    Patients

    Seq Age Sex Outcome Treatment
    1