BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PERCUTANEOUS SHEATH INTRODUCER SET

    MDR report key: 3566515 · Received January 9, 2014

    Report

    Report Number
    2015691-2014-00075
    Event Type
    Malfunction
    Date Received
    January 9, 2014
    Date of Event
    December 11, 2013
    Report Date
    December 11, 2013
    Manufacturer
    EDWARDS LIFESCIENCES PR
    Product Code
    DQY
    PMA / PMN Number
    E172813
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    WE WERE ABLE TO EVALUATE THE SHIPPING DAMAGE FROM PHOTOS SENT BY DHL. EXAMINATION OF THE PHOTOS FOUND THE CORNER OF THE OUTER CARDBOARD CORRUGATED BOX HAS BEEN CRUSHED AND RIPPED OPEN AND THE DAMAGE EXTENDING INTO THE PRODUCT LABEL. THE PRODUCT INSIDE THE BOX WAS DAMAGED AND THAT THE STERILITY OF THE PRODUCT HAS BEEN COMPROMISED. ADDITIONAL INFORMATION WILL BE FORTHCOMING AS RECEIVED. A REVIEW OF THE MANUFACTURING RECORDS INDICATED THAT THE PRODUCT MET SPECIFICATIONS UPON RELEASE.

    Description of Event or Problem · 1

    AS REPORTED, THE CARTON WAS TORN. DAMAGED PRODUCTS WERE NOTICED INSIDE OF THE CARTON. THE STERILITY OF THE DEVICES IS COMPROMISED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    16826 PERCUTANEOUS SHEATH INTRODUCER SET CATHETER, PERCUTANEOUS DQY EDWARDS LIFESCIENCES PR I450BF85 59610508

    Patients

    Seq Age Sex Outcome Treatment
    1