BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SI BRITE TIP

    MDR report key: 4162208 · Received October 10, 2014

    Report

    Report Number
    9616099-2014-00644
    Event Type
    Malfunction
    Date Received
    October 10, 2014
    Date of Event
    September 23, 2014
    Report Date
    September 23, 2014
    Manufacturer
    CORDIS CORPORATION
    Product Code
    DYB
    PMA / PMN Number
    K984500
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    COMPLAINT CONCLUSION: THE SITE REPORTED THAT A 5F 23CM BRITE TIP CATHETER SHEATH INTRODUCER (CSI) HAD A FRAYED TIP. THERE WAS NO REPORTED PATIENT INJURY. NO FURTHER INFORMATION REGARDING THIS EVENT WAS PROVIDED. A NON-STERILE SI BRITE TIP PRODUCT WAS RECEIVED ON NOV 03 2014. IP F5 23CM CANNULA SHEATH COMPONENT WAS RECEIVED FOR ANALYSIS INSIDE A PLASTIC BAG. PER VISUAL ANALYSIS, THE CANNULA SHEATH INTRODUCER WAS RECEIVED FRAYED/ SPLIT/ TORN DAMAGED. NO ORIGINAL PACKAGING WAS RETURNED FOR ANALYSIS AS TO DETERMINE IF COMPLAINT CONDITION COULD BE CAUSED DUE TO IMPROPER PACKAGING. BLOOD RESIDUES WERE OBSERVED INSIDE THE CANNULA SHEATH. 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. REVIEW OF LOT 16036213 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 16036213. THE CANNULA BTS FUSING FPI/ LPI AND PARAMETERS RESULTS WERE REVIEWED AND NO ANOMALIES WERE FOUND. THE CANNULA FPI/ LPI AND MONITORING MOLDING RESULTS WERE REVIEWED AND NO ANOMALIES WERE FOUND. CALIBRATION RECORD FOR FUSING MACHINE WITH CALIBRATION ID: (B)(4) WAS REVIEWED, AND IT WAS FOUND THAT THE EQUIPMENT WAS CALIBRATED IN A TIMELY MANNER. THE LOT INVOLVED IN THE COMPLAINT WAS MANUFACTURED WITHIN THE CALIBRATION DATE. PREVENTIVE MAINTENANCE RECORD FOR FUSING MACHINE WITH EQUIPMENT ID: (B)(4) WERE REVIEWED, AND IT WAS FOUND THAT THE PREVENTIVE MAINTENANCE WAS EXECUTED DURING THE ESTABLISHED TIME PERIOD. THE LOT INVOLVED IN THE COMPLAINT WAS MANUFACTURED WITHIN THE PREVENTIVE MAINTENANCE DATE. CALIBRATION RECORD FOR MOLDING MACHINES WITH CALIBRATION ID¿S: (B)(4) WERE REVIEWED, AND IT WAS FOUND THAT THE EQUIPMENTS WERE CALIBRATED IN A TIMELY MANNER. THE LOT INVOLVED IN THE COMPLAINT WAS MANUFACTURED WITHIN THE CALIBRATION DATES. PREVENTIVE MAINTENANCE RECORDS FOR MOLDING MACHINES WITH EQUIPMENT ID¿S: (B)(4) WERE REVIEWED, AND IT WAS FOUND THAT THE PREVENTIVE MAINTENANCES WERE EXECUTED DURING THE ESTABLISHED TIME PERIODS. THE LOT INVOLVED IN THIS COMPLAINT WAS MANUFACTURED WITHIN THE PREVENTIVE MAINTENANCE DATES. THE PRODUCT MALFUNCTION CODE COMPLAINT REPORTED BY THE CUSTOMER AS ¿ENDOVASCULAR VASCULAR ACCESS-BRITE TIP/DISTAL TIP-FRAYED/SPLIT/TORN¿ WAS CONFIRMED DUE TO THE CONDITION OF CANNULA SHEATH DISTAL TIP DAMAGED RECEIVED. HOWEVER, THE EXACT CAUSE OF THE FRAYED/SPLIT/TORN CONDITION FOUND ON THE CANNULA SHEATH COULD NOT BE CONCLUSIVELY DETERMINED DURING THE ANALYSIS. ANALYSIS RESULTS AND DHR REVIEW RESULTS DO NOT SUGGEST THAT THIS DAMAGE IS RELATED TO THE MANUFACTURING PROCESS. PROCEDURAL FACTORS, HANDLING AND STORAGE PROCESS MAY CONTRIBUTE TO THE FAILURE AS REPORTED. AS ADDITIONAL INVESTIGATION THE CSI MANUFACTURING PROCESS WAS REVIEWED AND THERE WERE NOT TOOLS, EQUIPMENT OR PRODUCT HANDLING THAT COULD CAUSE FRAYED/SPLIT/TORN OR OTHER TYPE OF DAMAGES ON THE CSI UNITS. IN ADDITION, THE CSI UNITS ARE INSPECTED DURING MANUFACTURING PROCESS FOR ANY TYPE OF DAMAGE; ALSO, SEVERAL INSPECTIONS ARE PERFORMED THROUGH ALL THE CSI ASSEMBLY PROCESS OPERATIONS. NO CORRECTIVE OR PREVENTIVE ACTIONS WILL BE TAKEN AT THIS TIME, GIVEN THAT THE REPORTED FAILURES DO NOT APPEAR TO BE RELATED TO THE MANUFACTURING PROCESS. THE PRODUCT INSTRUCTIONS FOR USE (IFU) STATES THAT THE VESSEL DILATOR FACILITATES THE PERCUTANEOUS ENTRY OF THE CSI BY FORMING AN ATRAUMATIC TRANSITION FROM THE SKIN THROUGH THE SUBCUTANEOUS TISSUE TO THE VESSEL. THE IFU CAUTIONS THE USER TO NOT USE THE DEVICE IF THE PACKAGE IS OPENED OR DAMAGED. THE IFU FURTHER CAUTIONS THE USER TO INVESTIGATE THE CAUSE OF ANY RESISTANCE DURING INSERTION BEFORE CONTINUING WITH THE PROCEDURE. IF THE CAUSE OF THE RESISTANCE CANNOT BE DETERMINED AND CORRECTED, THE USER IS INSTRUCTED DISCONTINUE THE PROCEDURE. LASTLY, THE USER IS INSTRUCTED NOT WITHDRAW THE DILATOR UNTIL THE CSI IS IN THE VESSEL TO AVOID DAMAGE TO THE CSI TIP. BASE ON THE LIMITED INFORMATION PROVIDED, IT IS NOT POSSIBLE TO DRAW A CONCLUSION ABOUT A CLINICAL RELATIONSHIP BETWEEN THE DEVICE AND THE EVENT. THE REPORTED ¿DISTAL TIP ¿ FRAYED/SPLIT/TORN¿ EVENT WAS CONFIRMED THROUGH VISUAL ANALYSIS. THE EXACT CAUSE OF THE FAILURE COULD NOT BE DETERMINED; THOUGH IT MAY HAVE BEEN RELATED TO HANDLING ISSUES. NEITHER THE DHR REVIEW NOR THE PRODUCT ANALYSIS SUGGESTS THAT THE REPORTED FAILURE COULD BE RELATED TO THE MANUFACTURING OF THIS UNIT. THEREFORE, NO CORRECTIVE ACTIONS WILL BE TAKEN.

    Additional Manufacturer Narrative · 1

    (B)(6). THE GENDER OF THE PATIENT IS UNKNOWN. THIS DEVICE IS AVAILABLE FOR ANALYSIS BUT HAS NOT YET BEEN RECEIVED. ADDITIONAL INFORMATION IS PENDING AND WILL BE SUBMITTED WITHIN 30 DAYS UPON RECEIPT.

    Additional Manufacturer Narrative · 1

    ACCORDING TO THE AFFILIATE, THERE IS NO FURTHER INFORMATION AVAILABLE. 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 COMPLAINT PRODUCT WAS RETURNED FOR ANALYSIS. THIS DEVICE IS AVAILABLE FOR ANALYSIS BUT THE ENGINEERING REPORT IS NOT YET AVAILABLE. HOWEVER, IT WILL BE SUBMITTED WITHIN 30 DAYS UPON RECEIPT.

    Description of Event or Problem · 1

    AS REPORTED, THE TIP OF A 5F 23CM BRITE TIP SHEATH WAS NOT MANUFACTURED PROPERLY (FRAYED). THERE WAS NO PATIENT INJURY REPORTED. THE DEVICE WILL BE RETURNED FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    639305 SI BRITE TIP ENDOVASCULAR VASCULAR ACCESS (DYB) DYB CORDIS CORPORATION 401523M 16036213

    Patients

    Seq Age Sex Outcome Treatment
    1