BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NIM® EMG - ENDOTRACHEAL TUBE - TRIVANTAGE®

    MDR report key: 4932966 · Received July 22, 2015

    Report

    Report Number
    1045254-2015-00243
    Event Type
    Injury
    Date Received
    July 22, 2015
    Date of Event
    June 27, 2015
    Report Date
    June 27, 2015
    Manufacturer
    MEDTRONIC XOMED INC.
    Product Code
    ETN
    PMA / PMN Number
    K112686
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NO
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    BLANK FIELDS ON THIS REPORT ARE THE RESULT OF INFORMATION NOT BEING PROVIDED BY INITIAL REPORTER. THIS DEVICE IS USED FOR THERAPEUTIC PURPOSES. (B)(4).

    Additional Manufacturer Narrative · 1

    DATE OF THIS REPORT: 06/27/2015. DESCRIBE EVENT PROBLEM: ADDITIONAL INFORMATION RECEIVED: IT WAS REPORTED THAT ¿ABOUT 25 MINUTES BEFORE THE SURGERY WAS DONE, THE ANESTHESIA MACHINE WOULD NOT GIVE THE TIDAL VOLUME THAT WAS SET. I [ANESTHESIOLOGIST] IMMEDIATELY REALIZED THAT THE CUFF WAS LEAKING AND TRIED TO FILL MORE AIR IN THE CUFF. IT DID NOT WORK. WE HAND VENTILATED PATIENT AND DIDN¿T INTUBATE THE PATIENT AGAIN.¿ DATE MANUFACTURER RECEIVED: 07-23-2015.

    Additional Manufacturer Narrative · 1

    DATE OF THIS REPORT: 06/27/2015. DEVICE AVAILABLE FOR EVALUATION? YES. RETURNED TO MANUFACTURER: 08/31/2015. DATE RECEIVED BY MANUFACTURER: 09/09/2015. PRODUCT EVALUATION: FOR ANALYSIS, RECEIVED 1 UN-SEALED SAMPLE, PART NUMBER 8229737, FROM LOT NUMBER 0209443736; THERE WAS EVIDENCE OF BIOLOGICAL CONTAMINANTS [BASED OFF OF THE REACTIVITY WITH HYDROGEN PEROXIDE] AND A RESIDUE CONSISTENT WITH TAPE ADHESIVE WHICH IS CONSISTENT WITH INTUBATION AND THE REPORTED EVENT. THE ELECTRODES CONTAINING SHARPS WERE CHECKED FOR ANOMALIES AND THEN SCRAPPED. WHEN COMPARED TO THE ASSEMBLY DRAWING: VISUALLY, THERE WAS A JAGGED 3/8¿ TEAR AND A 0.04¿ PUNCTURE IN THE CUFF WHICH WOULD HAVE RESULTED IN THE REPORTED EVENT. THE TEAR WAS APPROXIMATELY PERPENDICULAR TO THE MAIN TUBE. A SYRINGE WAS USED TO INJECT AIR INTO THE CUFF AND IT WOULD NOT INFLATE. VISUAL ASSEMBLY INSTRUCTIONS REQUIRES MANUFACTURING TO PERFORM A 100% CUFF INFLATION TEST WHICH WOULD HAVE DETECTED THE DAMAGE IF PRESENT AT THE TIME OF THE TEST. THERE WAS NO DAMAGE TO THE PACKAGING THAT WOULD INDICATE A CAUSE FOR THE OBSERVED DAMAGE. THE INSTRUCTIONS FOR USE WARN THE USER TO FIRST PERFORM A CUFF INFLATION TEST AND VISUALLY CHECK FOR ABNORMALITY; THE OBSERVED DEFECT WOULD HAVE BEEN DETECTED DURING AN INFLATION TEST IF PRESENT AT THE TIME OF THE TEST. THE INSTRUCTIONS FOR USE INDICATES THAT DAMAGE MAY OCCUR TO THE DEVICE DURING ACTIONS SUCH AS; OVER INFLATION, INSERTION OF OBJECTS, AND BITING FORCES. THE INFORMATION LIKELY INDICATES THAT THE CUFF WAS DAMAGED DURING, OR AFTER INTUBATION. (B)(4).

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT ¿THE PATIENT WAS A BIT DIFFICULT TO INTUBATE, BUT IT WENT FINE. 1 HOUR AND 40 MINUTES AFTER THE INTUBATION THEY GOT A LEAK IN THE CUFF. IT IS NOT POSSIBLE TO INFLATE AIR INTO THE CUFF. TO GET ENOUGH AIR INTO THE PATIENT THEY HAD TO HAVE HIGH FRESH GAS FLOW AND THEY HAD TO BAG THE PATIENT MANUALLY.¿ THERE WAS NO PATIENT IMPACT.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED: IT WAS REPORTED THAT "ABOUT 25 MINUTES BEFORE THE SURGERY WAS DONE, THE ANESTHESIA MACHINE WOULD NOT GIVE THE TIDAL VOLUME THAT WAS SET. I [ANESTHESIOLOGIST] IMMEDIATELY REALIZED THAT THE CUFF WAS LEAKING AND TRIED TO FILL MORE AIR IN THE CUFF. IT DID NOT WORK. WE HAND VENTILATED PATIENT AND DIDN'T INTUBATE THE PATIENT AGAIN."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    475853 NIM® EMG - ENDOTRACHEAL TUBE - TRIVANTAGE® STIMULATOR, NERVE ETN MEDTRONIC XOMED INC. 8229737 0209443736

    Patients

    Seq Age Sex Outcome Treatment
    1 00053 YR Required Intervention