BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDOTRACHEAL TUBE 7.5 MM EMG FLEX

    MDR report key: 1782829 · Received July 28, 2010

    Report

    Report Number
    1045254-2010-00032
    Event Type
    Injury
    Date Received
    July 28, 2010
    Date of Event
    July 1, 2010
    Report Date
    July 1, 2010
    Manufacturer
    MEDTRONIC XOMED, INC.
    Product Code
    BTR
    PMA / PMN Number
    K925640
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE REPORTER INDICATED THAT THE TUBE WOULD BE RETURNED, BUT THE TUBE HAS NOT BEEN RECEIVED. IF THE TUBE IS RETURNED, ADDITIONAL INFORMATION WILL BE SUBMITTED ON A SUPPLEMENTAL MDR. THE CUSTOMER REPORTED THERE WAS NO CONSEQUENCE TO THE PATIENT, AND SHE IS DOING FINE. ANY MISSING OR INCOMPLETE DATA ON FORM 3500A IS THE RESULT OF INFORMATION NOT BEING PROVIDED OR RELEASED BY THE REPORTER DESPITE ATTEMPTS TO OBTAIN THE REQUIRED INFORMATION. THERE WAS NO CONSEQUENCE TO THE PATIENT AND SHE IS DOING FINE.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED DURING BALANCED ANESTHESIA, PROBLEMS WITH THE OXYGEN SUPPLY TO THE PATIENT DURING SURGERY DUE TO AN OCCLUSION OF THE FLEX EMG TUBE. APPROXIMATELY 15 MINUTES INTO THE PROCEDURE, HE NOTED, THE CUFF HAD INFLATED OVER THE DISTAL TIP OF THE EMG TUBE. THE EMG TUBE WAS REPLACED WITH ANOTHER FLEX EMG TUBE OF A DIFFERING LOT. REFERENCE: WHILE THE DEVICE THAT IS THE SUBJECT OF THIS REPORT IS NOT SOLD IN THE U.S. AND DOES NOT HAVE A 510K, A SIMILAR EMG TUBE (DIFFERENT MATERIALS/DESIGN) IS SOLD IN THE U.S. UNDER 510K (K925640).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDOTRACHEAL TUBE 7.5 MM EMG FLEX ENT BTR MEDTRONIC XOMED, INC. 8229975 66811500

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR Required Intervention