BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MALLINCKRODT

    MDR report key: 5882974 · Received August 17, 2016

    Report

    Report Number
    2936999-2016-00651
    Event Type
    Malfunction
    Date Received
    August 17, 2016
    Date of Event
    June 24, 2016
    Report Date
    July 21, 2016
    Manufacturer
    COVIDIEN
    Product Code
    BTR
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE PRODUCT PART NUMBER IN THIS REPORT IS NOT SOLD IN THE US HOWEVER, A SIMILAR PRODUCT ID (B)(4)TRACHEAL TUBE 510K NO. K941246 IS. ADDITIONAL PATIENT INFORMATION (ID, SEX, WEIGHT) AS WELL AS ADDITIONAL INFORMATION ASSOCIATED WITH THE COMPLAINT HAVE BEEN REQUESTED AND IS EITHER UNKNOWN, WILL NOT BE MADE AVAILABLE TO MEDTRONIC, OR WILL BE PROVIDED AND UPDATED IN A SUPPLEMENTAL REPORT.

    Additional Manufacturer Narrative · 1

    (B)(4). ONE SAMPLE WAS RETURNED FOR EVALUATION. VISUAL EXAMINATION CONFIRMS THAT THERE IS A HOLE IN THE MAIN STEM OF THE TUBING. THE HOLE IS LOCATED IN THE TAIL NOTCH AREA.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT AFTER INTUBATING THE PATIENT THE DOCTOR NOTICED AIR LEAKAGE FROM THE TUBE. DURING INTUBATION THE PATIENTS TIDAL VOLUME WAS STABLE. THE OPERATION ENDED WITHOUT ANY ISSUES HOWEVER, AFTER THE PATIENT WAS EXTUBATED A HOLE BETWEEN THE INFLATION LINE AND THE TUBE WAS OBSERVED.THE PATIENT WAS (B)(6) OLD. NULATION OF A REPLACEMENT TUBE REQUIRED?: NO.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    536388 MALLINCKRODT 4.0MM RAE ORAL CUFF 86209 X10 BTR COVIDIEN 115-40 201505295X

    Patients

    Seq Age Sex Outcome Treatment
    1