BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MALLINCKRODT

    MDR report key: 1786103 · Received July 30, 2010

    Report

    Report Number
    2936999-2010-01039
    Event Type
    Malfunction
    Date Received
    July 30, 2010
    Date of Event
    June 17, 2010
    Report Date
    June 30, 2010
    Manufacturer
    COVIDIEN, FORMERLY TYCOHEALTHCARE
    Product Code
    BTR
    PMA / PMN Number
    K841872
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4) IS NOT DISTRIBUTED IN THE UNITED STATES; HOWEVER, THERE IS A DEVICE OF ESSENTIALLY IDENTICAL DESIGN DISTRIBUTED BY COVIDIEN IN THE US. PLEASE REFER TO 510K# K841872. THE CUSTOMER INDICATED THAT THE SAMPLE ASSOCIATED TO THIS REPORT IS EXPECTED TO BE RETURNED TO THE MANUFACTURING SITE FOR ANALYSIS. IF SIGNIFICANT INFORMATION IS IDENTIFIED FROM THE SAMPLE ANALYSIS, A SUMMARY OF THE INVESTIGATION RESULTS WILL BE PROVIDED IN A SUPPLEMENTAL REPORT. SEE SCANNED PAGE.

    Description of Event or Problem · 1

    THE COMPANY RECEIVED A REPORT THAT THE PATIENT WAS INTUBATED WITH THE DEVICE FOR OPERATION ON THE JAW. IT WAS REPORTED THAT 2.30 HRS FOLLOWING THE OPERATION, THE PATIENT EXPERIENCED A PRESSURE INCREASE RESULTING FROM A BRONCHOSPASM. THE PATIENT'S JAWS WERE BLOCKED PREVENTING EXTUBATION OF THE TUBE. THE CALLER REPORTED THAT THE CUFF RETURNED TO NORMAL PRESSURE AFTER 3.30 HRS AND EXTUBATION OF THE DEVICE WAS PERFORMED. THE CALLER REPORTED THAT VISUAL INSPECTION OF THE TUBE REVEALED THAT THE CUFF WAS HERNIATED. REINTUBATION WAS NOT REQUIRED, AS THE TUBE WAS BEING REMOVED POST OPERATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MALLINCKRODT SAFETY FLEX CUFFED 5.5MM X10 BTR COVIDIEN, FORMERLY TYCOHEALTHCARE

    Patients

    Seq Age Sex Outcome Treatment
    1