BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CATHETER AND CANNULA

    MDR report key: 3072589 · Received April 18, 2013

    Report

    Report Number
    1828100-2013-00358
    Event Type
    Malfunction
    Date Received
    April 18, 2013
    Date of Event
    March 28, 2013
    Report Date
    March 29, 2013
    Manufacturer
    TERUMO CARDIOVASCULAR SYSTEMS CORP.
    Product Code
    DWF
    PMA / PMN Number
    K890024
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    UPON RECEIPT OF THE DEVICE (DURING PREPARATION AFTER UNPACKING), THE USER REPORTED THAT THE CUSTOMER FOUND A BLACK SUBSTANCE ADHERING ON THE 7 MM ARTERIAL CANNULA. HE TRIED TO REMOVE IT BY WIPING IT, BUT IT WOULD NOT COME OFF. HE BELIEVES IT WAS ADHERING INSIDE THE CANNULAE. THERE WAS NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    168387 CATHETER AND CANNULA DWF TERUMO CARDIOVASCULAR SYSTEMS CORP. 6392 0685664

    Patients

    Seq Age Sex Outcome Treatment
    1