BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CONTINUOUS TRAY WITH 100MM NEEDLE STIMULATING & 61CM CATHETER

    MDR report key: 5209673 · Received November 8, 2015

    Report

    Report Number
    2026095-2015-00313
    Event Type
    Malfunction
    Date Received
    November 8, 2015
    Date of Event
    October 7, 2015
    Report Date
    October 9, 2015
    Manufacturer
    HALYARD HEALTH - IRVINE
    Product Code
    CAZ
    PMA / PMN Number
    PK073187
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). METHODS: THE DEVICE WAS REPORTED AS NOT AVAILABLE FOR RETURN AND ANALYSIS. HOWEVER A REVIEW OF THE DEVICE HISTORY RECORD (DHR) WAS CONDUCTED FOR THE REPORTED MODE AND LOT NUMBER. RESULTS: INSPECTION RECORDS FOR THE (B)(4) CATHETER SHOW NO REJECTIONS RECORDED DURING THE INSPECTION PERFORMED. IN PROCESS EVALUATION WAS PERFORMED AND NO ROOT CAUSE WAS IDENTIFIED FOR DAMAGE TO THE CATHETER AS THE ASSESSMENT DID NOT FIND ANY ACTIVITY IN THE MANUFACTURING PROCESS THAT COULD HAVE LED TO AFFECT THE INTEGRITY OF THE COMPONENTS INSIDE THE TRAY. CONCLUSION: THE DEVICE WAS NOT RETURNED TO (B)(4) FOR TESTING; THEREFORE WE ARE UNABLE TO DETERMINE A CAUSE FOR THE REPORTED INCIDENT. THE DHR ASSESSMENT DID NOT FIND ANY ACTIVITY IN THE MANUFACTURING PROCESS THAT COULD HAVE LED TO THE REPORTED INCIDENT, THERE WERE NO REJECTIONS RECORDED DURING THE INSPECTION. ADDITIONAL INFORMATION HAS BEEN REQUESTED, HOWEVER NOT YET RECEIVED. SHOULD ADDITIONAL INFORMATION PERTINENT TO THIS EVENT BECOME AVAILABLE, HALYARD WILL SUBMIT A FOLLOW-UP REPORT. PLEASE NOTE: THE SPIROL CATHETER BELONGS TO A PERIPHERAL NERVE BLOCK TRAY THAT IS ASSEMBLED FOR (B)(4), AND THE SUSPECT CATHETER MENTIONED IN THIS INCIDENT IS A COMPONENT OF THE TRAY AND AN (B)(4) PRODUCT. FOR THIS CATHETER, THE PRODUCT CODE IS BSO, AND THE 510K NUMBER IS K133316. INFORMATION FROM THIS INCIDENT HAS BEEN INCLUDED IN OUR PRODUCT COMPLAINT TREND REPORTING SYSTEMS FOR MONITORING, TRACKING AND TRENDING. NOT RETURNED TO MFG.

    Description of Event or Problem · 1

    A CATHETER BREAK WAS REPORTED AND FURTHER DESCRIBED AS A CATHETER CAME APART WHILE INSIDE A PATIENT. FURTHER INFORMATION WAS NOT REPORTED AND THE DEVICE IS NOT AVAILABLE FOR ANALYSIS. PHOTOGRAPHIC IMAGES WERE PROVIDED BY THE REPORTER AND THE CATHETER APPEARS TO BE BROKEN IN SEVERAL PIECES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    739958 CONTINUOUS TRAY WITH 100MM NEEDLE STIMULATING & 61CM CATHETER ANESTHESIA CONDUCTION KIT CAZ HALYARD HEALTH - IRVINE TBT02100ST 0202168068

    Patients

    Seq Age Sex Outcome Treatment
    1