BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARTERIAL CANNULA

    MDR report key: 1935904 · Received December 3, 2010

    Report

    Report Number
    1828100-2010-02367
    Event Type
    Malfunction
    Date Received
    December 3, 2010
    Date of Event
    November 4, 2010
    Report Date
    December 3, 2010
    Manufacturer
    TERUMO CARDIOVASCULAR SYSTEMS CORP.
    Product Code
    DWF
    PMA / PMN Number
    K934127
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    EVAL IN PROGRESS, BUT NOT YET CONCLUDED.

    Description of Event or Problem · 1

    DURING INCOMING INSPECTION OF THE DEVICE, OUR FOREIGN CONSIGNEE REPORTED A CUT IN THE PEEL PACK THAT PENETRATED THROUGH TO THE BACK SHEET OF THE PACKAGING. NO OTHER DETAILS REGARDING THE NATURE OF THE EVENT WERE PROVIDED. SINCE THE EVENT OCCURRED DURING INCOMING INSPECTION OF THE DEVICE, THERE WAS NO PT INVOLVEMENT DURING THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ARTERIAL CANNULA CANNULA DWF TERUMO CARDIOVASCULAR SYSTEMS CORP. 6392 0609906

    Patients

    Seq Age Sex Outcome Treatment
    1