BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARDINAL HEALTH

    MDR report key: 19095253 · Received April 12, 2024

    Report

    Report Number
    3005670221-2024-00015
    Event Type
    Malfunction
    Date Received
    April 12, 2024
    Report Date
    April 12, 2024
    Manufacturer
    JIANGSU CAINA MEDICAL CO., LTD.
    Product Code
    FMF
    UDI-DI
    10192253034677
    PMA / PMN Number
    K113091
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE RETURNED SAMPLE IS UNAVAILABLE FOR EVALUATION. THE DHR OF THIS LOT WAS REVIEWED WITHOUT ANY ISSUE. THE DESIGN HISTORY FILE AND 510K SUMBSSION WERE REVIEWED. THIS SYRINGE IS DESIGNED FOR MANUAL USE ONLY, NOT FOR PUMP USE. FOR MANUAL USE OR NOT FOR PUMP USE WAS NOT PRESENTED ON ANY LABELING OF THIS PRODUCT. THE COMPLIANT HISTORY WAS REVIEWED FIVE PUMP COMPATBILITY ISSUES WITH THIS PRODUCT WERE RECEIVED BEFORE. A RECALL WAS CONDUCTED BY DISTRIBUTOR CARDINAL HEALTH 200 LLC WITH RECALL NUMBER Z-0855-2024. THE CORRETIVE ACTION PUTTING THE CAUTION "FOR MANUAL USE OR NOT FOR PUMP USE" ON ALL SYRINGES' LABELING OF K113091 WILL BE TAKEN. A FOLLOW-UP REPORT WILL BE SUBMITTED IF ANY ADDITIONAL INFORMATION FROM THE RECEIVED SAMPLES.

    Description of Event or Problem · 0

    IT WAS REPORTED ANONYMOUSLY VIA MEDWATCH THAT THEIR HOSPITAL USES MONOJECT SYRINGES. THE REPORTER STATED THAT MONOJECT SYRINGES WERE PREVIOUSLY MANUFACTURED BY COVIDIEN. THEY HAVE RECENTLY CHANGED TO CARDINAL HEALTH. CARDINAL HEALTH IS USING THE SAME REFERENCE NUMBER AND MONOJECT NAME, BUT THE SYRINGES ARE DIFFERENT. THE REASON THIS IS AN ISSUE IS BECAUSE THEIR HOSPITAL USES THE MONOJECT SYRINGES ON THEIR MEDFUSION PUMPS. THE MEDFUSION PUMPS ARE PROGRAMMED WITH THE PARAMETERS OF THE SYRINGE. NOW, WHEN THEY PUT THE MONOJECT SYRINGE ON THE MEDFUSION PUMP, IT CANNOT BE RECOGNIZED. THEY HAVE REPORTED THIS ISSUE TO CARDINAL HEALTH BUT NO RESOLUTION YET. THE REPORTER STATED THAT THEY ARE CONCERNED BECAUSE HOSPITALS ACROSS THE COUNTRY USE MEDFUSION SYRINGE PUMPS AND WHEN THEY GO TO RUN A POTENTIALLY LIFE SUSTAINING MEDICATION WITH A CARDINAL HEALTH MONOJECT SYRINGE IT WILL NOT WORK ON THE SYRINGE PUMPS. IT SEEMS THAT CARDINAL HEALTH SHOULD NOTIFY ALL OF ITS CUSTOMERS OF THIS ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1412994 CARDINAL HEALTH SYRINGE FMF JIANGSU CAINA MEDICAL CO., LTD. 221201 10192253034677

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other