BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARTERIAL CANNULA

    MDR report key: 2172139 · Received June 24, 2011

    Report

    Report Number
    1828100-2011-01758
    Event Type
    Malfunction
    Date Received
    June 24, 2011
    Date of Event
    May 31, 2011
    Report Date
    June 24, 2011
    Manufacturer
    TERUMO CARDIOVASCULAR SYSTEM CORP.
    Product Code
    DWF
    PMA / PMN Number
    K890024
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    UPON RECEIPT OF THE DEVICE, THE USER REPORTED THE BOX OF CANNULA WAS NOT SHIPPED IN AN OUTER BOX. THE USER COULD NOT TAKE THE BOX INTO THE OPERATING ROOM. SINCE THE EVENT OCCURRED UPON RECEIPT, THERE WAS NO PATIENT INVOLVEMENT DURING THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ARTERIAL CANNULA CANNULA AND CATHETER DWF TERUMO CARDIOVASCULAR SYSTEM CORP. 4949

    Patients

    Seq Age Sex Outcome Treatment
    1