BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MCKESSON BRANDS

    MDR report key: 19887280 · Received August 1, 2024

    Report

    Report Number
    1451040-2024-00039
    Event Type
    Malfunction
    Date Received
    August 1, 2024
    Date of Event
    March 25, 2024
    Report Date
    August 1, 2024
    Manufacturer
    JIANGSU CAINA MEDICAL CO.,LTD
    Product Code
    FMF
    Product Problem
    Yes
    Report Source
    Distributor report
    Reporter Location
    AZ, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    IT WAS REPORTED BY THE CUSTOMER THAT THE SYRINGE WAS BEING USED TO INJECT CHEMOTHERAPY INTO THE BAG AND THE LUER LOCK TIP BROKE OFF FROM THE SYRINGE RESULTING IN SPILL INSIDE OF THE IV HOOD. THE SPILL WAS IMMEDIATELY CLEANED. EMPLOYEE'S PERSONAL PROTECTIVE EQUIPMENT WAS REPLACED. THE DRUG WAS WASTED, AND THE DOSE WAS REMADE FOR THE PATIENT. THE CHEMICAL AGENT DID NOT REACH THE PATIENT. NO INFORMATION WAS RECEIVED REGARDING ANY SERIOUS INJURY AS A RESULT OF THIS PRODUCT ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    863682 MCKESSON BRANDS SYRINGE, LL 60CC FMF JIANGSU CAINA MEDICAL CO.,LTD CJCC11-02

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown