BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SI BRITE TIP

    MDR report key: 2123473 · Received June 14, 2011

    Report

    Report Number
    9616099-2011-00416
    Event Type
    Malfunction
    Date Received
    June 14, 2011
    Date of Event
    May 17, 2011
    Report Date
    May 19, 2011
    Manufacturer
    CORDIS DE MEXICO
    Product Code
    DYB
    PMA / PMN Number
    K984500
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT HAS BEEN RETURNED FOR EVALUATION, BUT THE ANALYSIS IS NOT YET COMPLETE. ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN 30 DAYS FROM RECEIPT. 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 15312624 REVEALED NO ANOMALIES DURING THE MANUFACTURING AND INSPECTION PROCESSES THAT CAN BE ASSOCIATED WITH THE REPORTED COMPLAINT. ONE UNIT WAS REJECTED DURING THE FINAL ASSEMBLY OF THIS LOT. THE DHR REVIEW CONFIRMED THAT THE REJECTED UNIT WAS PROPERLY SEGREGATED AND DISCARDED. 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 15312624. THE OPERATOR QUALIFICATION RECORDS FOR PACKAGING, ACCORDING TO MWI 7500555 REV: 47 AND THE OPERATOR QUALIFICATION RECORDS FOR SEAL TRAY AND LABEL TRAY ACCORDING TO (B)(4) WERE REVIEWED. THE OPERATORS THAT PERFORMED THESE OPERATIONS WERE QUALIFIED ON THE APPROPRIATE MANUFACTURING WORK INSTRUCTIONS REVISIONS AT THE TIME OF THE LOT MANUFACTURING.

    Additional Manufacturer Narrative · 1

    THE PRODUCT ANALYSIS WAS COMPLETED; THEREFORE, WAS UPDATED. THE COMPLAINT RECEIVED STATES THAT THERE WAS A FOREIGN SUBSTANCE INSIDE OF THE STERILE PACKAGE OF THE BRITE TIP SHEATH. DURING UNPACKING THE SHEATH ON THE TABLE, 2 HAIRS WERE INSIDE. ONE HAIR IS LOST. THE HAIR IS PACKED IN THE GAUZE IN THE PACKAGE. THE PRODUCT WAS NOT USED IN THE PATIENT AND WILL BE RETURNED FOR ANALYSIS. THE DEVICE WAS STORED PER THE INSTRUCTIONS FOR USE. THERE WAS NO DAMAGE OBSERVED WITH THE PACKAGING OR THE DEVICE. THE DEVICE WAS NOT USED IN THE PATIENT. THERE IS NO REPORT OF INJURY FOR THE PATIENT. ONE NON STERILE OPENED PACKAGE TRAY WAS RECEIVED WITHOUT THE PRODUCT. INSIDE THE PACKAGE TRAY WAS ONE CONTAMINATED GAUZE. THE GAUZE CONTAMINATION WAS BLOOD LIKE AND INSIDE OF THE GAUZE WAS ONE HAIR. AT A GLANCE NO ADDITIONAL 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 EXACT CAUSE OF THE FAILURE REPORTED BY THE CUSTOMER COULD NOT BE CONCLUSIVELY DETERMINED DUE TO ONE HAIR WAS RECEIVED WITH THE OPENED TRAY PACKAGE. CONTROLS ARE IN PLACE TO PREVENT THIS TYPE OF FAILURE FROM LEAVING THE FACILITY, REFER TO MANUFACTURING WORK INSTRUCTION (B)(4). NO CORRECTIVE ACTION WILL BE TAKEN AT THIS TIME SINCE AS THERE ARE NO INDICATIONS THAT THE COMPLAINT IS RELATED TO MANUFACTURING PROCESS. THE COMPLAINT OF FOREIGN SUBSTANCE IN THE STERILE PACKAGE WAS CONFIRMED ON ANALYSIS; HOWEVER, THE EXACT CAUSE OF THE CONFIRMED FAILURE COULD NOT BE DETERMINED. THERE IS NO EVIDENCE OF MANUFACTURING OR DESIGN ISSUES THAT CONTRIBUTED TO THE EVENT. NO CORRECTIVE ACTION IS REQUIRED AT THIS TIME. INSPECTIONS ARE IN PLACE TO ENSURE THAT NO DAMAGED PRODUCTS LEAVE THE FACILITY. REVIEW OF THE INFORMATION DOES NOT SUGGEST WHAT OTHER FACTORS MAY HAVE CONTRIBUTED TO THE CONFIRMED EVENT.

    Description of Event or Problem · 1

    DURING UNPACKING THE SHEATH ON THE TABLE, 2 HAIRS WERE INSIDE. 1 HAIR IS LOST. THE HAIR IS PACKED IN THE GAUZE IN THE PACKAGE. THE PRODUCT WAS NOT USED IN THE PATIENT AND WILL BE RETURNED FOR ANALYSIS. THE DEVICE WAS STORED PER THE INSTRUCTIONS FOR USE. THERE WAS NO DAMAGE OBSERVED WITH THE PACKAGING OR THE DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SI BRITE TIP ENDOVASCULAR VASCULAR ACCESS (DYB) DYB CORDIS DE MEXICO NA 15312624

    Patients

    Seq Age Sex Outcome Treatment
    1