BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TEXIUM NEEDLE-FREE SYRINGE

    MDR report key: 4840828 · Received June 12, 2015

    Report

    Report Number
    9616066-2015-00771
    Event Type
    Malfunction
    Date Received
    June 12, 2015
    Report Date
    June 4, 2015
    Manufacturer
    CAREFUSION
    Product Code
    FPA
    PMA / PMN Number
    K071108
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    NO PRODUCT WILL BE RETURNED PER CUSTOMER. THE CUSTOMER COMPLAINT COULD NOT BE CONFIRMED BECAUSE THE PRODUCT WAS DISCARDED AND NOT RETURNED FOR FAILURE INVESTIGATION. THE ROOT CAUSE OF THIS FAILURE WAS NOT IDENTIFIED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT A LEAK OCCURED AT THE BONDED JUNCTION OF THE SYRINGE AND TEXIUM DEVICE WHILE AN IV PUSH OF ADRIAMYCIN WAS IN PROGRESS. THE CUSTOMER REPORTED THAT SOME OF THE CHEMOTHERAPY DRUG LEAKED ONTO THE PATIENT AND IT WAS QUICKLY REMOVED. THE CUSTOMER REPORTED NO PATIENT HARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    384708 TEXIUM NEEDLE-FREE SYRINGE SET, ADMINISTRATION, INTRAVASCULAR FPA CAREFUSION MY8030

    Patients

    Seq Age Sex Outcome Treatment
    1