BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CONTINUOUS TRAY WITH 100MM NEEDLE STIMULATING

    MDR report key: 4884046 · Received July 1, 2015

    Report

    Report Number
    2026095-2015-00187
    Event Type
    Malfunction
    Date Received
    July 1, 2015
    Date of Event
    June 5, 2015
    Report Date
    June 8, 2015
    Manufacturer
    HALYARD - IRVINE
    Product Code
    CAZ
    PMA / PMN Number
    PK073187
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). METHOD: THE DEVICE WAS REPORTED TO BE RETURNING FOR AN EVALUATION AND AT THIS TIME IS PENDING RETURN. A REVIEW OF THE DEVICE HISTORY RECORD (DHR) FOR THE REPORTED LOT NUMBER IS CURRENTLY IN PROCESS. RESULTS: AT THIS TIME THE INVESTIGATION IS STILL IN PROGRESS. ONCE THE DEVICE IS RECEIVED, TESTING WILL BE PERFORMED AND RESULTS WILL BE PROVIDED ONCE COMPLETED. CONCLUSIONS: ONCE THE INVESTIGATION AND DEVICE ANALYSIS ARE COMPLETED A FOLLOW-UP REPORT WILL BE SUBMITTED. INFORMATION FROM THIS INCIDENT HAS BEEN INCLUDED IN OUR PRODUCT COMPLAINT AND MDR TREND REPORTING SYSTEMS. TREND INFORMATION IS USED TO IDENTIFY THE NEED FOR ADDITIONAL INVESTIGATIONS. PLEASE NOTE: THE SPIROL CATHETER WITH STYLET BELONGS TO A PERIPHERAL NERVE BLOCK TRAY THAT IS ASSEMBLED BY HALYARD; THE SUSPECT CATHETER MENTIONED IN THIS INCIDENT IS A COMPONENT OF THE TRAY AND AN EPIMED PRODUCT. FOR THIS CATHETER, THE PRODUCT CODE IS BSO AND THE 510K NUMBER IS K133316. DEVICE RETURN ANTICIPATED.

    Additional Manufacturer Narrative · 1

    METHOD: THE ACTUAL DEVICE WAS RECEIVED AND EVALUATED. A VISUAL INSPECTION WAS PERFORMED ALONG WITH A REVIEW OF THE DEVICE HISTORY RECORD (DHR) AND PROCESS EVALUATION. PHOTOGRAPHIC IMAGES WERE TAKEN AND THE DEVICE WAS INSPECTED UNDER MAGNIFICATION. A USE REVIEW WAS PERFORMED ALONG WITH A REVIEW OF THE INSTRUCTIONS FOR USE (IFU). RESULTS: VISUAL OBSERVATION FOUND THAT THE DEVICE WAS DAMAGED AT THE PROXIMAL END OF THE CATHETER. THE OUTER SHEATH PORTION OF THE CATHETER WAS BROKEN AND THE INTERNAL METAL COIL WAS STRETCHED. THE PROXIMAL END OF THE CATHETER WAS MISSING. CATHETER WAS EXAMINED UNDER MAGNIFICATION AND THE PROXIMAL END OF THE CATHETER APPEARED TO BE SHEARED OFF. THE END WAS NOT FLAT OR PERPENDICULAR TO THE CATHETER SLEEVE. THE COIL COMING OUT OF THE PROXIMAL END OF THE CATHETER WAS CONFIRMED. INCOMING INSPECTION RECORDS FOR THE CATHETER SHOWS NO REJECTIONS RECORDED DURING INSPECTION PERFORMED. VISUAL INSPECTION ENTAILS TO VERIFY THAT ALL COMPONENTS, HOLES AND MARKINGS WERE PRESENT, HAD NO VISIBLE KINKS, CRACKS OR DEBRIS AND CATHETER IS COILED IN SLEEVE; FUNCTIONAL INSPECTION ENTAILS TO VERIFY STYLET CAN BE REMOVED AND REINSERTED AND CATHETER DIMENSIONAL MEASUREMENTS MEET THE SPECIFICATION CRITERIA. PER THE PROCESS REVIEW AND DHR REVIEW THERE WERE NO IDENTIFIED ISSUES OBSERVED DURING THE MANUFACTURING PROCESS WHICH WOULD HAVE CONTRIBUTED TO THE OBSERVED EVENT. REVIEW OF THE INSTRUCTION FOR USE WAS PERFORMED, PREVENTION FOR REPORTED FAILURE MODE (SHEARING OF THE CATHETER) IS INCLUDED: "SUGGESTED INSTRUCTIONS FOR USE: THREAD DISTAL TIP OF CATHETER (MARKED WITH CM GRADUATIONS) THROUGH PROPERLY PLACED EPIDURAL NEEDLE OF CHOICE INTO THE EPIDURAL SPACE. ENCLOSED THREADING ASSIST GUIDE MAY BE INSERTED INTO NEEDLE HUB TO AID IN FEEDING CATHETER THROUGH NEEDLE. A SLIGHT INCREASE IN ADVANCEMENT PRESSURE WILL BE NOTED WHEN TIP OF CATHETER REACHES CURVED POINT OF EPIDURAL NEEDLE. SUBSEQUENT PRESSURE REQUIRED TO ADVANCE THE CATHETER INTO THE EPIDURAL SPACE SHOULD BE MINIMAL. CAUTION: IF EXCESSIVE RESISTANCE IS ENCOUNTERED, STOP, REMOVE BOTH NEEDLE AND CATHETER AS A UNIT AND ATTEMPT NEW PUNCTURE. TO AVOID SHEARING CATHETER, NEVER WITH DRAW CATHETER BACK AGAINST NEEDLE BEVEL." CONCLUSION: BASED ON THE INVESTIGATION AND THE SAMPLE EVALUATION, THE MOST LIKELY ROOT CAUSE OF THIS EVENT WAS INCORRECT USE OF THE DEVICE. THE INVESTIGATION FOUND DAMAGE AND THE CATHETER APPEARED TO BE SHEARED OFF. THE END WAS NOT FLAT OR PERPENDICULAR TO THE CATHETER SLEEVE. IF THE CATHETER IS NOT WITHDRAWN AT THE SAME TIME AS THE NEEDLE YOU RUN THE RISK OF SHEERING THE CATHETER. A REVIEW WAS PERFORMED AND THERE WERE NO ADDITIONAL CONFIRMED COMPLAINTS FOUND IN THE ETQ COMPLAINT HANDLING MODULE ASSOCIATED WITH THIS LOT NUMBER. INFORMATION FROM THIS INCIDENT HAS BEEN INCLUDED IN OUR PRODUCT COMPLAINT AND MDR TREND REPORTING SYSTEMS.

    Description of Event or Problem · 1

    PROCEDURE: TOTAL KNEE REPLACEMENT. CATHPLACE: ADDUCTOR CANAL BLOCK. IT WAS REPORTED THAT AN INCIDENT OF A CATHETER BREAK OCCURRED FURTHER DESCRIBED AS THE INNER COIL OF THE CATHETER CAME OUT WHEN THE CATHETER STYLET WAS REMOVED. THE DEVICE IS AVAILABLE FOR RETURN. ADDITIONAL INFORMATION WAS RECEIVED ON 06/10/2015. ULTRASOUND GUIDANCE WAS USED DURING NEEDLE/CATHETER PLACEMENT. THE CATHETER WAS ADVANCED 1CM BEYOND THE NEEDLE TIP. DURING REMOVAL OF STYLET, THERE WAS NO RESISTANCE INITIALLY; HOWEVER, AS THE STYLET WAS ALMOST AT THE END OF THE CATHETER, MORE RESISTANCE WAS MET. IT WAS NOTED THAT A FILAMENT TYPE MATERIAL EXITED THE CATHETER ALONG WITH THE STYLET. THE CATHETER WAS REMOVED INTACT. THERE WAS NO PATIENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    427884 CONTINUOUS TRAY WITH 100MM NEEDLE STIMULATING ANESTHESIA CONDUCTION KIT CAZ HALYARD - IRVINE TBT02100ST 020283687

    Patients

    Seq Age Sex Outcome Treatment
    1