BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SI BRITE TIP

    MDR report key: 2073586 · Received May 2, 2011

    Report

    Report Number
    9616099-2011-00293
    Event Type
    Malfunction
    Date Received
    May 2, 2011
    Date of Event
    April 4, 2011
    Report Date
    April 4, 2011
    Manufacturer
    CORDIS DE MEXICO
    Product Code
    DYB
    PMA / PMN Number
    K984500
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INFORMATION RECEIVED INDICATED THAT WHEN THE PACKAGE WAS OPENED, THE DILATOR OF THE BRITE TIP SHEATH INTRODUCER WAS FOUND PROTRUDING AND BROKE THROUGH THE INNER POUCH. THEREFORE, ANOTHER PRODUCT OF UNKNOWN BRAND WAS OPENED AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THE COMPLAINT PRODUCT WAS NOT CLINICALLY USED. THE DEVICES ARE STORED ACCORDING TO THE IFU. THE DEVICES ARE REMOVED FROM THE OUTER BOXES WHEN STORED. IT IS NOT KNOWN IF THERE WAS ANY DAMAGE TO THE OUTER BOX. ONE NONE STERILE SHEATH INTRODUCER UNIT WAS RECEIVED IN ITS ORIGINAL PACKAGING, THE POUCH IS CLOSED, AND IT NOT HAS BEEN OPENED. THE POUCH WAS FOLDED AT THE END OF THE TIP VESSEL DILATOR INTO THE ORIGINAL BOX (OPENED) AND THE FOLDED POUCH SECTION RESULTED IN PRESSURE ON THE TIP OF THE VESSEL DILATOR. THE VESSEL DILATOR WAS OUT OF POSITION IN THE MOUNTING CARD AND THE POUCH IS DAMAGED/TORN IN THE AREA OF THE TIP OF THE VESSEL DILATOR. NO OTHER ANOMALIES WERE FOUND. A REVIEW OF THE MANUFACTURING DOCUMENTATION ASSOCIATED WITH THIS LOT PRESENTED NO ISSUES DURING THE MANUFACTURING PROCESS THAT CAN BE RELATED TO THE REPORTED COMPLAINT. THE FAILURE REPORTED BY THE CUSTOMER WAS CONFIRMED; THE POUCH WAS COMPROMISED. THE VESSEL DILATOR WAS NOT PROTRUDING OUT OF THE POUCH BUT IT WAS OUT OF POSITION ON THE MOUNTING CARD. THERE IS NO INDICATION THAT IT IS RELATED TO THE MANUFACTURING PROCESS. A REVIEW OF THE MANUFACTURING DOCUMENTATION ASSOCIATED WITH THIS LOT PRESENTED NO ISSUES DURING THE MANUFACTURING PROCESS THAT CAN BE RELATED TO THE REPORTED COMPLAINT. REVIEW OF LOT 15105689 REVEALED NO ANOMALIES DURING THE MANUFACTURING AND INSPECTION PROCESSES THAT CAN BE ASSOCIATED WITH THE REPORTED COMPLAINT. THE EXACT CAUSE AND TIMING OF THE EVENT AS RELATED TO PACKAGING/SHIPPING, REMOVAL FROM THE SHIPPING BOX, AND STORAGE CANNOT BE DETERMINED. CONTROLS ARE IN PLACE TO PREVENT THIS TYPE OF FAILURE FROM LEAVING THE FACILITY. THEREFORE, NO CORRECTIVE ACTIONS WILL BE TAKEN AT THIS TIME.

    Additional Manufacturer Narrative · 1

    THE DEVICE IS AVAILABLE FOR EVALUATION, BUT HAS NOT BEEN RETURNED YET. A REVIEW OF THE MANUFACTURING DOCUMENTATION ASSOCIATED WITH THIS LOT PRESENTED NO ISSUES DURING THE MANUFACTURING PROCESS THAT CAN BE RELATED TO THE REPORTED COMPLAINT. REVIEW OF LOT 15105689 REVEALED NO ANOMALIES DURING THE MANUFACTURING AND INSPECTION PROCESSES THAT CAN BE ASSOCIATED WITH THE REPORTED COMPLAINT. NO UNITS WERE REJECTED DURING THE FINAL ASSEMBLY OF THIS LOT NO OTHER ISSUES WERE NOTED THAT WERE CONSIDERED POTENTIALLY RELATED TO THE REPORTED COMPLAINT. NO NONCONFORMANCE RECORDS WERE ISSUED FOR THIS LOT. NO EXCURSIONS WERE FOUND FOR LOT 15105689. ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN 30 DAYS FROM RECEIPT.

    Description of Event or Problem · 1

    THE INFORMATION RECEIVED INDICATED THAT WHEN THE PACKAGE WAS OPENED, THE DILATOR OF THE BRITE TIP SHEATH INTRODUCER WAS FOUND PROTRUDING THE INNER POUCH AND BROKE THE INNER POUCH. THEREFORE, ANOTHER PRODUCT OF UNKNOWN BRAND WAS OPENED AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THE COMPLAINT PRODUCT WAS NOT CLINICALLY USED. THERE WILL BE A PRODUCT RETURN. THE DEVICES ARE STORED ACCORDING TO THE IFU. THE DEVICES ARE REMOVED FROM THE OUTER BOXES WHEN STORED. THE PROCEDURE WAS FOR THE OPTEASE FILTER RETRIEVAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SI BRITE TIP ENDOVASCULAR VASCULAR ACCESS (DYB) DYB CORDIS DE MEXICO NA 15105689

    Patients

    Seq Age Sex Outcome Treatment
    1