BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CONTINUOUS TRAY WITH 100MM NEEDLE, NON STIMULA

    MDR report key: 4138707 · Received October 1, 2014

    Report

    Report Number
    2026095-2014-00190
    Event Type
    Malfunction
    Date Received
    October 1, 2014
    Date of Event
    September 5, 2014
    Report Date
    September 5, 2014
    Manufacturer
    I-FLOW LLC
    Product Code
    CAZ
    PMA / PMN Number
    K073187
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    METHOD: THE DEVICE WAS RECEIVED FOR AN EVAL. A VISUAL INSPECTION WAS PERFORMED. THE DEVICE LOT NUMBER IS UNAVAILABLE, AS THE INFO WAS NOT SAVED BY THE HOSPITAL NURSE STAFF. THEREFORE, A REVIEW OF THE DEVICE HISTORY RECORD (DHR) CANNOT BE CONDUCTED. RESULTS: AT THIS TIME THE RESULTS ARE PENDING THE COMPLETION OF THE EVAL AND INVESTIGATION WHICH IS CURRENTLY IN PROCEDURES. CONCLUSIONS: A CONCLUSION IS NOT YET AVAILABLE AS THE INVESTIGATION AND EVAL OF THE PRODUCT IS STILL IN PROGRESS, AND HAS NOT BEEN COMPLETED. ONCE THE INVESTIGATION AND DEVICE ANALYSIS ARE COMPLETED A FOLLOW-UP REPORT WILL BE SUBMITTED. INFO FROM THIS INCIDENT WILL BE INCLUDED IN PRODUCT COMPLAINT AND MDR REPORTING SYSTEM. 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 510K NUMBER IS K133316.

    Description of Event or Problem · 1

    PROCEDURE: UNK. CATHPLACE: SAPHENOUS NERVE BLOCK. IT WAS REPORTED BY AN I-FLOW PRODUCT SALES REP, THAT AN ANESTHESIOLOGIST REPORTED AN INCIDENT OF A CATHETER BECOMING KINKED AND SHEARING DURING A NERVE BLOCK PROCEDURE. WHILE HE WAS INSERTING THE SPIROL CATHETER THROUGH THE ECHO NEEDLE, HE MET RESISTANCE WHEN HE REACHED THE TIP OF THE NEEDLE. THE PHYSICIAN ATTEMPTED TO REPOSITION THE CATHETER AND AS SOON AS HE PULLED BACK ON THE CATHETER, IT KINKED. AFTER THE CATHETER KINKED THE ANESTHESIOLOGIST REMOVED THE CATHETER AND THE CATHETER SHEARED DURING REMOVAL. THE NEEDLE WAS STILL IN PLACE WHEN HE PULLED BACK ON THE CATHETER. ALL CATHETER PIECES WERE REMOVED AND NO INJURY OCCURRED. A NEW KIT WAS USED TO COMPLETE THE NERVE BLOCK. NO OTHER MEDICAL INTERVENTION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    611133 CONTINUOUS TRAY WITH 100MM NEEDLE, NON STIMULA ANESTHESIA CONDUCTION KIT CAZ I-FLOW LLC TBT02100T UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR 4INCH ECHO NEEDLE| DRUG: ROPIVACAINE 0.5%