BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CATHETER, IRRIGATION

    MDR report key: 7137504 · Received December 21, 2017

    Report

    Report Number
    7137504
    Event Type
    Malfunction
    Date Received
    December 21, 2017
    Date of Event
    December 12, 2017
    Report Date
    December 13, 2017
    Manufacturer
    CARDINAL HEALTH
    Product Code
    FEH
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    PRIOR TO UTILIZING ON PATIENT, THE TRUMPET VALVE DEVICE WAS TESTED BY THE ATTENDING SURGEON. THE RED BUTTON DID NOT PROPERLY FUNCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    917739 CATHETER, IRRIGATION FEH CARDINAL HEALTH ASU1201 041730

    Patients

    Seq Age Sex Outcome Treatment
    1