BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CUSA EXCEL 36KHZ TUBING SET

    MDR report key: 6134583 · Received November 30, 2016

    Report

    Report Number
    3006697299-2016-00213
    Event Type
    Malfunction
    Date Received
    November 30, 2016
    Date of Event
    November 7, 2016
    Report Date
    November 7, 2016
    Manufacturer
    INTEGRA LIFESCIENCES(IRELAND)
    Product Code
    LFL
    PMA / PMN Number
    K141674
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INTEGRA HAS COMPLETED THEIR INTERNAL INVESTIGATION ON 12/12/2016. THE FAILURE ANALYSIS WAS NOT POSSIBLE SINCE COMPLAINT UNIT HAS NOT BEEN RECEIVED AT THE (B)(4) SITE FOR EVALUATION AND NO PICTURE WAS PROVIDED BY THE REPORTING FACILITY. DEVICE HISTORY RECORD (DHR) OF MANUFACTURING LOT 1162526 WAS REVIEWED. ACCORDING TO THE DHR REVIEW, NO ANOMALIES WERE REPORTED DURING THE PACKAGING PROCESSES OF THIS LOT THAT COULD BE RELATED TO THE REPORTED CONDITION. NO PATIENT HARM WAS REPORTED AS PART OF THIS INCIDENT. NO SIMILAR COMPLAINTS RELATED TO ¿STERILE PACKAGING INSIDE IS STAINED AND HAS A CHEMICAL SMELL¿ HAVE BEEN REPORTED FOR FG LOT 1162526. AFTER REVIEWING THE COMPLAINT SYSTEM SINCE NOVEMBER 2014 TO NOVEMBER 2016, ONLY ONE (B)(4) COMPLAINT ((B)(4)) RELATED TO THE REPORTED CONDITION HAS BEEN REPORTED IN CUSA MANIFOLD TUBING FAMILY AT INTEGRA LIFESCIENCES (B)(4) FACILITY. (B)(4).. CONCLUSION: THE FAILURE ANALYSIS OF COMPLAINT UNIT IS REQUIRED TO DETERMINE THE DEFINITE ROOT CAUSE OF THE REPORTED CONDITION. THEREFORE, IT IS NOT POSSIBLE TO DETERMINE A ROOT CAUSE FOR THE REPORTED CONDITION AT THIS TIME. THE REPORTED CONDITION COULD NOT BE CONFIRMED BASED ON THE INFORMATION PROVIDED BY THE REPORTING FACILITY SINCE COMPLAINT UNIT HAS NOT BEEN RETURNED FOR EVALUATION AND NO PICTURES WERE PROVIDED. MANUFACTURING PROCESS OF CUSA MANIFOLD TUBING WAS INSPECTED AND NO OPERATION WAS FOUND IN WHICH A STERILE PACKAGE STAINED AND WITH CHEMICAL SMELL COULD BE POSSIBLE

    Additional Manufacturer Narrative · 1

    PRODUCT RETURNED. INVESTIGATION COMPLETED 3/23/2017: METHOD: -FAILURE ANALYSIS: SIX (6) UNITS FROM CATALOG C3601, CUSA EXCEL 36 KHZ TUBING SET CORRESPONDING TO FG LOT # 1162526 WERE RECEIVED FOR EVALUATION. RETURNED UNITS WERE RECEIVED UNOPENED WITHIN THE ORIGINAL PACKAGES. THE VISUAL EVALUATION OF THE DEVICES IDENTIFIED THAT THE TYVEK LIDS OF THE PACKAGES ARE STAINED BUT NO CHEMICAL SMELL WAS DETECTED. CONCLUSION: THE REPORTED CONDITION WAS CONFIRMED WITH THE EVALUATION BUT, THE CONDITION OF ¿HAS A CHEMICAL SMELL¿ COULD NOT BE CONFIRMED WITH THE EVALUATION OF THE RETURNED UNITS. FOR CUSA EXCEL 36KHZ TUBING SET PRODUCTS, EACH INNER AND OUTER TRAY IS CLEANED WITH ALCOHOL 70% AND LINT FREE WIPES DURING OPERATION 90 (CUSA TRAYS CLEANING). SUBSEQUENTLY DURING OPERATION, THE MANIFOLD TUBING IS PLACED INTO THE INNER TRAY. NO REJECT WAS REPORTED AS A RESULT OF THESE OPERATIONS. MANIFOLD TUBING ASSEMBLY IS 100% VISUALLY INSPECTED. NO REJECT WAS REPORTED AS RESULT OF THIS OPERATION AS PER DHR OF MANUFACTURING LOT 1162526. ALSO, QUALITY PERSONNEL INSPECTED VISUALLY THE MANIFOLD TUBING ASSEMBLY AND NO REJECT WAS REPORTED AS THE OUTCOME OF THE QUALITY INSPECTION (OPERATION 160). THE FG LOT 1162526 WAS STERILIZED ON (B)(6) 2016 UNDER STERILIZATION LOT FE-16183. THE STERILIZATION DOCUMENTATION WAS REVIEWED AND NO DEVIATION WAS REPORTED AGAINST THE ASSESSED LOT THAT COULD CAUSE A STAINED NOR CHEMICAL SMELL IN THE PACKAGES. NO ADDITIONAL COMPLAINTS RELATED TO ¿STERILE PACKAGING INSIDE IS STAINED AND HAS A CHEMICAL SMELL¿ HAVE BEEN REPORTED TO FG LOT 1162526. IN ADDITION, THE ORIGINAL CORRUGATED CARTON WAS NOT RECEIVED AS PART OF THE COMPLAINT RETURNED UNITS TO OBTAIN MORE INFORMATION ABOUT THE EVENT. THE POTENTIAL ROOT CAUSE MAY BE RELATED TO A SPILLAGE OF A SUBSTANCE DURING THE TRANSIT OF THE PRODUCT TO THE USER OR DURING THE STORAGE OF THE PRODUCT AT THE USER FACILITY. NO ASSIGNABLE CAUSES THAT COULD BE ASSOCIATED TO THE MANUFACTURING PROCESS NEITHER DURING THE STERILIZATION PROCESS WERE DETERMINED BASED ON THE REVIEW OF THE DHR, CAPA'S AND NCR'S HISTORY. IN ADDITION, PROCESS CONTROLS ARE IN PLACE TO DETECT THE REPORTED CONDITION.

    Description of Event or Problem · 1

    ON (B)(6) 2016 THE C3601 CUSA EXCEL 36KHZ TUBING SET WAS FOUND TO HAVE STAINING INSIDE THE STERILE PACKAGING AND HAS A CHEMICAL SMELL. THE STAINING HAD SEEPED INTO THE PACKAGING AND WAS ON THE PRODUCT. THE OUTER BOX ITSELF WAS IN PREFECT CONDITION. THERE WAS NO PATIENT CONTACT OR INJURY OR DELAY IN PROCEDURE, BUT STERILITY WAS COMPROMISED FOR THE DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    787721 CUSA EXCEL 36KHZ TUBING SET ULTRASONIC SURGICAL PRODUCTS LFL INTEGRA LIFESCIENCES(IRELAND) 1162526

    Patients

    Seq Age Sex Outcome Treatment
    1