BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PERCUTANEOUS SHEATH INTRODUCER KIT

    MDR report key: 2212248 · Received August 15, 2011

    Report

    Report Number
    2015691-2011-16045
    Event Type
    Malfunction
    Date Received
    August 15, 2011
    Date of Event
    July 15, 2011
    Report Date
    July 18, 2011
    Manufacturer
    EDWARDS LIFESCIENCES, PR
    Product Code
    DYB
    PMA / PMN Number
    K885179
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE TRAY WAS RETURNED FOR EVALUATION WITHOUT ANY ATTACHED COMPONENTS. CATHETER OR OTHER COMPONENTS WERE NOT RETURNED WITH THE TRAY. TAPE WAS ATTACHED ON THE TRAY AND ONE PARTICULATE WAS ATTACHED ON THE TAPE. A CARDBOARD-LIKE PARTICULATE APPROXIMATELY 1MM LONG WAS VISIBLE ON THE TAPE ATTACHED TO THE TRAY. VISUAL EXAMINATIONS WERE PERFORMED UNDER MICROSCOPE AT 10X MAGNIFICATION. CHEMISTRY TESTING FOUND THE SUBSTANCE SHOWED SIMILAR ABSORPTION CHARACTERISTICS WHEN COMPARED TO CELLULOSE-LIKE MATERIAL. ALTHOUGH THE COMPLAINT WAS CONFIRMED, THERE ARE NO INDICATIONS THAT THIS IS RELATED TO THE MANUFACTURING PROCESS. THE ORIGIN OF THE PARTICULATE COULD NOT BE CONCLUSIVELY DETERMINED. NO ACTIONS WILL BE TAKEN AT THIS TIME. THE LOT NUMBER WAS NOT PROVIDED; THEREFORE, A DEVICE HISTORY RECORD REVIEW COULD NOT BE PERFORMED.

    Additional Manufacturer Narrative · 1

    THE DEVICE EVALUATION IS IN PROGRESS. A SUPPLEMENTAL REPORT WILL BE SENT WITH THE INVESTIGATION RESULTS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT "UNKNOWN MATERIAL, WHICH LOOKED LIKE A PIECE OF TRASH, WAS OBSERVED INSIDE THE PACKAGE WHEN IT WAS OPENED." NO PATIENT INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PERCUTANEOUS SHEATH INTRODUCER KIT INTRODUCERS STANDARD DYB EDWARDS LIFESCIENCES, PR M095F85J 58956326

    Patients

    Seq Age Sex Outcome Treatment
    1