BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARDINAL

    MDR report key: 19687260 · Received July 8, 2024

    Report

    Report Number
    3005670221-2024-00185
    Event Type
    Malfunction
    Date Received
    July 8, 2024
    Date of Event
    June 25, 2024
    Report Date
    July 8, 2024
    Manufacturer
    JIANGSU CAINA MEDICAL CO., LTD.
    Product Code
    FMF
    PMA / PMN Number
    K151949
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE RETURNED SAMPLES AND LOT NUMBER OF THIS EVENT WAS REQUESTED BUT HASN'T BEEN RECEIVED TILL NOW, NO SAMPLE FOR EVALUATION AND NO DHR FOR REVIEW. THE ISSUE CAN'T BE CONFIRMED, CARDINAL HEALTH CHANGED THE BRAND FROM COVIDEN TO CARDINAL HEALTH. THE CUSTOMER DID NOT USE TO THE NEW CARDINAL HEALTH BRAND. THE INSULIN SYRINGE WAS NOT INTENDED USING WIH MICROCLAVE CLEAR NEUTRAL CONNECTOR EITHER THE ROOT CAUSE CAN'T DETECTED "CURRENTLY". NO ACTION WILL BE TAKEN CURRENTLY, THIS ISSUE WILL BE MONITORED. A SUPPLEMENTAL REPORT WILL BE SUBMITTED IF FURTHER INFORMATION RECEIVED.

    Description of Event or Problem · 0

    CUSTOMER FEEDBACK: 1.THE DESIGN OF THE INSULIN SYRINGE HAS BEEN CHANGED, SAME REFERENCE NUMBER, BUT SYRINGES ARE DIFFERENT; 2.WHEN USED WITH A MICROCLAVE CLEAR NEUTRAL CONNECTOR (REF: MC100), THE PREVIOUS DESIGN BY COVIDIEN ALLOWED THE ENTIRE CONTENTS OF THE SYRINGE TO BE ADMINISTERED INTO THE PATIENT'S IV LINE. THE NEW DESIGN BY CARDINAL HEALTH DOES NOT ALLOW FOR ALL OF THE CONTENTS OF THE SYRINGE TO BE ADMINISTERED INTO THE PATIENT'S IV LINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    193276 CARDINAL INSULIN SYRINGE FMF JIANGSU CAINA MEDICAL CO., LTD.

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other