BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ECHOTIP INSIGHT

    MDR report key: 18484251 · Received January 10, 2024

    Report

    Report Number
    18484251
    Event Type
    Malfunction
    Date Received
    January 10, 2024
    Date of Event
    August 3, 2023
    Report Date
    August 17, 2023
    Manufacturer
    COOK IRELAND LTD
    Product Code
    QIJ
    UDI-DI
    00827002465602
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    VA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    MALFUNCTION WHILE SETTING UP FOR PROCEDURE, UNABLE TO FLUSH HEPARIN THROUGH THE NEEDLE, UNABLE TO USE IT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1143094 ECHOTIP INSIGHT ENDOSCOPIC TRANSHEPATIC VENOUS ACCESS NEEDLE QIJ COOK IRELAND LTD G46560 C2068449 00827002465602

    Patients

    Seq Age Sex Outcome Treatment
    1 10585 DA Male