BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MALLINCKRODT

    MDR report key: 2903426 · Received January 2, 2013

    Report

    Report Number
    2936999-2012-00715
    Event Type
    Injury
    Date Received
    January 2, 2013
    Date of Event
    November 24, 2012
    Report Date
    December 4, 2012
    Manufacturer
    COVIDIEN, FORMERLY TYCO HEA, AVENIDA HENEQUEN
    Product Code
    BTR
    PMA / PMN Number
    K871204
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    IF THE SAMPLE IS RETURNED, A SUMMARY OF THE INVESTIGATION WILL BE PROVIDED IN A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    CUSTOMER REPORTED AFTER 11 DAYS USE ON PATIENT AT HOSPITAL, A NURSE CONFIRMED THE CUFF PRESSURE COULD NOT BE MEASURED. CUSTOMER CONFIRMED THAT PRETESTING OF THE TUBE WAS PERFORMED AND CONFIRMED NO HARM TO PATIENT. INFORMATION SUGGEST THAT REPLACEMENT OF THE TUBE REQUIRED HOWEVER, IT IS NOT CONFIRMED. COVIDIEN HAS MADE MULTIPLE ATTEMPTS TO GATHER FURTHER DETAILS RELATED TO THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1338 MALLINCKRODT HI-LO TRACH TUBE BTR COVIDIEN, FORMERLY TYCO HEA, AVENIDA HENEQUEN

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention