BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CONTINUOUS TRAY WITH 100MM NEEDLE 4IN ECHO NEE

    MDR report key: 4152393 · Received October 3, 2014

    Report

    Report Number
    2026095-2014-00191
    Event Type
    Malfunction
    Date Received
    October 3, 2014
    Date of Event
    September 8, 2014
    Report Date
    September 8, 2014
    Manufacturer
    I-FLOW LLC
    Product Code
    CAZ
    PMA / PMN Number
    K073187
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    METHOD: THE DEVICE IS NOT AVAILABLE FOR RETURN AS THE HOSPITAL STAFF DISPOSED OF THE DEVICE BEFORE IT COULD BE COLLECTED FOR RETURN. A REVIEW OF THE DEVICE HISTORY RECORD IS BEING CONDUCTED FOR THE LOT NUMBER REPORTED. RESULTS: AS THE DEVICE WAS UNAVAILABLE FOR AN EVAL, NO METHODS WERE PERFORMED AND RESULTS CANNOT BE OBTAINED. CONCLUSIONS: SINCE THE DEVICE WAS NOT RETURNED TO I-FLOW FOR EVAL, WE ARE UNABLE TO DETERMINE AN EXACT CAUSE FOR THE REPORTED EVENT. PLEASE NOTE: THE SPIROL CATHETER BELONGS TO A PERIPHERAL NERVE BLOCK TRAY THAT IS ASSEMBLED BY KIMBERLY CLARK, AND 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. IF ADDITIONAL INFO PERTINENT TO THIS COMPLAINT IS RECEIVED, A FOLLOW-UP REPORT WILL BE SUBMITTED. INFO FROM THIS INCIDENT HAS BEEN INCLUDED IN OUR PRODUCT COMPLAINT AND MDR TREND REPORTING SYSTEMS. TREND INFO IS USED TO IDENTIFY THE NEED FOR ADDITIONAL INVESTIGATION.

    Description of Event or Problem · 1

    PROCEDURE: TOTAL KNEE REPLACEMENT. CATHPATH: FEMORAL NERVE BLOCK. IT WAS REPORTED THAT A CATHETER STYLET WAS STUCK, AND DURING REMOVAL THE CATHETER SHEARED. THREADING THE CATHETER WAS NORMAL AND RESISTANCE WAS NOT MET. IT WAS ONLY WHEN THE CRNA ATTEMPTED TO REMOVE THE STYLET THAT THE CATHETER THEN BECAME STUCK. AFTER THE THIRD ATTEMPT THE STYLET CAME OUT, BUT SHEARED THE CATHETER. THE INNER COIL COMPLETELY PULLED OUT OF THE CATHETER. IT WAS REPORTED THAT THE CATHETER WAS REMOVED WITHOUT DIFFICULTY AND THE ENTIRE CATHETER WAS ACCOUNTED FOR AFTER THE CATHETER REMOVAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    617677 CONTINUOUS TRAY WITH 100MM NEEDLE 4IN ECHO NEE NERVE BLOC KIT CAZ I-FLOW LLC TBT02100T 0201374569

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR DRUG: NOT PROVIDED.