BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MALLINCKRODT

    MDR report key: 1786181 · Received July 30, 2010

    Report

    Report Number
    2936999-2010-01040
    Event Type
    Malfunction
    Date Received
    July 30, 2010
    Date of Event
    June 28, 2010
    Report Date
    July 2, 2010
    Manufacturer
    COVIDIEN, FORMERLY TYCOHEALTHCARE
    Product Code
    BTR
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4) IS NOT DISTRIBUTED IN THE U.S., HOWEVER; THERE IS A DEVICE OF ESSENTIALLY IDENTICAL DESIGN DISTRIBUTED IN THE US. PLEASE REFER TO 510K# K871204. NO SAMPLE IS EXPECTED TO BE RETURNED FOR EVALUATION. WITHOUT THE ACTUAL COMPLAINT SAMPLE BEING RETURNED AND THE LOT NUMBER OF THE PRODUCT, A FULL INVESTIGATION CANNOT BE CARRIED OUT. IF THE SAMPLE IS RECEIVED AT A LATER DATE AND/OR IF SIGNIFICANT INFO BECOMES AVAILABLE RELATED TO THIS REPORT, A SUMMARY WILL BE PROVIDED IN A SUPPLEMENTAL REPORT. INFO HAS BEEN ADDED TO THE DATABASE FOR TRENDING PURPOSES.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT A PINHOLE IN THE CUFF WAS DISCOVERED DURING PT USE. THE CUSTOMER COULD NOT CONFIRM IF EXTUBATION AND REINTUBATION OF A REPLACEMENT TUBE WAS REQUIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MALLINCKRODT 7.5MM LO CONTOUR MURPHY BTR COVIDIEN, FORMERLY TYCOHEALTHCARE

    Patients

    Seq Age Sex Outcome Treatment
    1