BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ECHOBRIGHT T-BLOC TRAY 100MM NEEDLE, NON STIMU

    MDR report key: 4672429 · Received April 7, 2015

    Report

    Report Number
    2026095-2015-00117
    Event Type
    Malfunction
    Date Received
    April 7, 2015
    Date of Event
    March 10, 2015
    Report Date
    March 10, 2015
    Manufacturer
    HALYARD
    Product Code
    CAZ
    PMA / PMN Number
    K073187
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    METHOD: THE DEVICE WAS REPORTED AS NOT AVAILABLE FOR RETURN AND ANALYSIS. THE REPORTER WAS UNABLE TO PROVIDE A LOT NUMBER; THUS, THE DEVICE HISTORY RECORD (DHR) REVIEW CANNOT BE CONDUCTED. THE INSTRUCTIONS FOR USE WERE REVIEWED. RESULTS: AS THE DEVICE AND LOT NUMBER WERE UNAVAILABLE FOR ANALYSIS, NO METHODS WERE PERFORMED. FOR THIS REASON RESULTS CANNOT BE OBTAINED. CONCLUSIONS: THE DEVICE WAS NOT RETURNED TO HALYARD FOR AN EVAL; THEREFORE WE ARE UNABLE TO DETERMINE THE CAUSE FOR THE REPORTED EVENT. NO PT INJURY WAS REPORTED. PER THE REPORTED INFO, THE ANESTHESIOLOGIST MET SOME RESISTANCE WHEN PULLING BACK THE STYLET. PLEASE NOTE: THE SPIROL CATHETER BELONGS TO A PERIPHERAL NERVE TRAY THAT IS ASSEMBLED BY HALYARD, 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. 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 ADD'L INVESTIGATIONS. SEE SCANNED PAGE.

    Description of Event or Problem · 1

    PLEASE REFERENCE: 2026095-2015-00118/ (B)(6). PROCEDURE: SHOULDER SCOPE. CATHPLACE: INTERSCALENE NERVE BLOCK. IT WAS REPORTED THAT AN ANESTHESIOLOGIST PERFORMED TWO SEPARATE PROCEDURE ON TWO PTS, AND DURING EACH SEPARATE PROCEDURE THE ANESTHESIOLOGIST EXPERIENCED A CATHETER SHEARING. IT WAS REPORTED THAT THE STYLET WASN'T "PULLING OUT" AFTER THE CATHETER HAD BEEN INSERTED. AS THE ANESTHESIOLOGIST WAS TRYING TO PULL THE STYLET BACK, THE CATHETER STARTED TO SHEAR. THE CATHETERS WERE REMOVED ON BOTH PTS AND REPLACED WITH A CATHETER FROM ANOTHER CATHETER KIT IN WHICH "THE STYLET PULLED OUT FINE". THE CATHETER FOR THIS REPORTED INCIDENT IS UNAVAILABLE FOR RETURN. ADD'L INFO WAS RECEIVED ON 03/12/2015. IT WAS REPORTED THAT THE SHEAR OF BOTH CATHETERS OCCURRED DURING THE REMOVAL OF STYLETS. FOR THE FIRST INCIDENT, THERE WAS LOT OF RESISTANCE WHEN PULLING THE STYLET OFF THE CATHETER. AT THIS POINT, THE NEEDLE WAS ALREADY PULLED BACK (SO NOT RELATED TO THE NEEDLE). WHEN THE ANESTHESIOLOGIST PULLED THE STYLET OUT, THE CATHETER STARTED SHEARING OUTSIDE OF THE PT. THE DOCTOR HAD TO REPLACE THE SHEARED CATHETER WITH A NEW CATHETER. NO PT INJURY OCCURRED. THE LOT NUMBER WAS NOT AVAILABLE. ADD'L INFO WAS RECEIVED ON 03/18/2015. IT WAS REPORTED THAT NO ADD'L INFO WAS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    228802 ECHOBRIGHT T-BLOC TRAY 100MM NEEDLE, NON STIMU ANESTHESIA CONDUCTION KIT CAZ HALYARD TBT01089T ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1