BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PERCUTANEOUS CATHETER INSERTION TRAY WITH 8 FRENCH INTRODUCER

    MDR report key: 1487996 · Received September 30, 2009

    Report

    Report Number
    2015691-2009-11705
    Event Type
    Malfunction
    Date Received
    September 30, 2009
    Date of Event
    September 3, 2009
    Report Date
    September 3, 2009
    Manufacturer
    EDWARDS LIFESCIENCES, PR
    Product Code
    DQY
    PMA / PMN Number
    K831729
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SW
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INITIAL EVALUATION INDICATED THAT THE DEVICE WAS MANUFACTURED USING ALPHAGARY; HOWEVER, FURTHER INVESTIGATION REVEALED THAT THE MATERIAL WAS COLORITE. THE COLORITE MATERIAL WAS SUBSTITUTED FOR THE ALPHAGARY MATERIAL. AN INVESTIGATION WAS PERFORMED AND COMPLETED FOR BROKEN BLUE CONNECTORS. THE COMPLAINTS RELATED TO BROKEN BLUE CONNECTORS ARE ASSOCIATED TO THE NON AUTOMATIC INTRODUCERS. THEY WERE ASSEMBLED USING THE HEMOVALVE MADE OUT WITH RESIN FROM COLORITE SUPPLIER. AS A PART OF THE MATERIALS INCOMING INSPECTION A VERIFICATION OF THE PARTS FOR CRACKS, VOID OR ANY MOLDING DEFECT WILL BE PERFORMED PRIOR TO THE RELEASE OF THE MATERIAL. OUR MANUFACTURING PROCESS HAS A 100% IN PROCESS VISUAL INSPECTION; ANY DEFECTIVE HOUSING WILL BE CAPTURE DURING THIS INSPECTION. SEVERAL TESTS HAVE BEEN PERFORMED WITH BOTH RESINS (COLORITE AND ALFAGARY). UNITS BUILT WITH THE ALFAGARY MATERIAL DID NOT BREAK DURING TESTING. IT WAS CONCLUDED THAT THE ALFAGARY MATERIAL WILL BE SUBSTITUTED FOR THE VALVE BODY.

    Additional Manufacturer Narrative · 1

    CUSTOMER REPORT WAS CONFIRMED. THE INTRODUCER RETURNED WAS BROKEN JUST ABOVE THE SIDE ARM EXTENSION TUBE. THE HOUSING APPEARS TO BE ALPHAGARY MATERIAL.

    Description of Event or Problem · 1

    ON SEPTEMBER 29, 2009, A DOCTOR REPORTED THAT A ZIRCONIA RESTORATION, WHICH HAD BEEN TREATED WITH SILANE, WAS SEATED USING NX3. THE RESTORATION FELL OFF ABOUT 1 MONTH AFTER PLACEMENT.

    Description of Event or Problem · 1

    C-CC-DC - KIT COMPONENTS DAMAGED OR OUT OF SPEC; IT WAS REPORTED THAT A PIECE OF THE PRODUCT CRACKED, AND BROKE DURING USE ON THE PATIENT. IT WAS FURTHER STATED THAT THE HOSPITAL SAID THE BLUE PART OF THE INTRODUCER BROKE DURING USE. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PERCUTANEOUS CATHETER INSERTION TRAY WITH 8 FRENCH INTRODUCER PERCUTANEOUS SHEATH INTRODUCER SET. DQY EDWARDS LIFESCIENCES, PR I451BF6 58738954

    Patients

    Seq Age Sex Outcome Treatment
    1