BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CONTINUOUS TRAY WITH 100MM NEEDLE, STIMULATING

    MDR report key: 4148056 · Received October 2, 2014

    Report

    Report Number
    2026095-2014-00193
    Event Type
    Malfunction
    Date Received
    October 2, 2014
    Date of Event
    September 11, 2014
    Report Date
    September 10, 2014
    Manufacturer
    I-FLOW LLC
    Product Code
    CAZ
    PMA / PMN Number
    K073187
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    METHOD: THE SUSPECT DEVICE WAS RECEIVED FOR ANALYSIS. A REVIEW OF THE DEVICE HISTORY RECORD IS IN PROGRESS. RESULTS: EVALUATION AND INVESTIGATION RESULTS WILL BE PROVIDED ONCE THEY ARE COMPLETED. CONCLUSIONS: AT THIS TIME THE INVESTIGATION AND ANALYSIS ARE STILL IN PROGRESS. A FOLLOW-UP REPORT WILL BE SUBMITTED UPON COMPLETION. INFO FROM THIS INCIDENT WILL BE INCLUDED IN OUR PRODUCT COMPLAINT AND MDR TREND REPORTING SYS. ADDITIONAL INVESTIGATION MAY ARISE FROM ONGOING ANALYSIS, TREND INFO, OR OTHER ANALYSIS AS APPROPRIATE. 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.

    Description of Event or Problem · 1

    PROCEDURE: UNK - ANP. CATHPLACE: INTERSCALENE BLOCK. IT WAS REPORTED BY AN ANESTHESIOLOGIST THAT A CATHETER FROM A REGIONAL ANESTHESIA TRAY SHEARED DURING AN INTERSCALENE BLOCK. DURING INSERTION OF THE CATHETER MINIMAL RESISTANCE WAS MET. UPON REMOVAL OF THE STYLET, THE STYLET WOULD NOT COME OUT. WHEN THE NEEDLE WAS REMOVED, HE NOTICED THERE WAS A SLIGHT SHEARING OF THE CATHETER. THE CATHETER WAS COMPLETELY REMOVED FROM THE PT. ANOTHER KIT WAS USED WITHOUT FURTHER ISSUE AND THERE WAS NO PT INJURY OR MED INTERVENTION REQUIRED. PT INFO IS NOT AVAILABLE AS THE NURSE COULD NOT RECALL SPECIFIC DETAILS FOR THE PT INVOLVED. ANP: ASKED NOT PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    615493 CONTINUOUS TRAY WITH 100MM NEEDLE, STIMULATING ANESTHESIA CONDUCTION KIT CAZ I-FLOW LLC TBT02100ST 0201416190

    Patients

    Seq Age Sex Outcome Treatment
    1 DRUG: ROPIVACAINE 30CC| SIMULATING NEEDLE