BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MALLINCKRODT

    MDR report key: 3093759 · Received April 30, 2013

    Report

    Report Number
    2936999-2013-00332
    Event Type
    Injury
    Date Received
    April 30, 2013
    Date of Event
    April 1, 2013
    Report Date
    April 3, 2013
    Manufacturer
    COVIDIEN
    Product Code
    BTR
    PMA / PMN Number
    K090352
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). NO SAMPLE IS EXPECTED TO BE RETURNED. WITHOUT THE ACTUAL COMPLAINT SAMPLE A FULL INVESTIGATION CANNOT BE COMPLETED THEREFORE, WE ARE UNABLE TO DETERMINE THE CAUSE FOR THIS SPECIFIC EVENT. MANUFACTURING CONTROLS ARE IN PLACE TO DETECT RELATED ISSUES AND TO REDUCE THE POTENTIAL FOR OCCURRENCE DURING THE MANUFACTURING PROCESS. INFORMATION OF THIS NATURE IS INCLUDED IN OUR DATABASE AND MONITORED THROUGH TRENDING.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED A LEAKAGE AT CUFF DISTAL AND PROXIMAL, LEAKAGE APPEARS AFTER INTUBATION. THE CUSTOMER CONFIRMED THAT EXTUBATION AND REINTUBATION OF A REPLACEMENT TUBE WAS REQUIRED. THE CUSTOMER CONFIRMED THE TUBE WAS PRETESTED. CUSTOMER CONFIRMED THAT THE TUBE WAS REPLACED WITHOUT FURTHER INCIDENT TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    186775 MALLINCKRODT TAPERGUARD ORAL/ NASAL TRACHEAL TUBE BTR COVIDIEN 120401795X

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention