BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARTERIAL CANNULA

    MDR report key: 2062015 · Received March 17, 2011

    Report

    Report Number
    1828100-2011-00860
    Event Type
    Malfunction
    Date Received
    March 17, 2011
    Date of Event
    February 15, 2011
    Report Date
    March 17, 2011
    Manufacturer
    TERUMO CARDIOVASCULAR SYSTEMS CORP.
    Product Code
    DWF
    PMA / PMN Number
    K930620
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE USER REPORTED THAT THE MATERIAL IS MUCH STIFFER THAN WHAT HAS BEEN USED IN THE PAST. THE USER IS QUESTIONING WHY THIS IS OCCURRING. THERE WERE NO REPORTED ADVERSE CONSEQUENCES TO THE PT AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ARTERIAL CANNULA CANNULA AND CATHETER DWF TERUMO CARDIOVASCULAR SYSTEMS CORP. L7302 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1