BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MALLINCKRODT

    MDR report key: 2932236 · Received January 22, 2013

    Report

    Report Number
    2936999-2013-00051
    Event Type
    Malfunction
    Date Received
    January 22, 2013
    Date of Event
    December 20, 2012
    Report Date
    December 26, 2012
    Manufacturer
    COVIDIEN, FORMERLY TYCOHEALTHCARE
    Product Code
    BTR
    PMA / PMN Number
    K090352
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    CUSTOMER STATES: DURING USE ON A PT AT HOSPITAL, A DOCTOR FELT THE CUFF WAS DEFLATED SOONER THAN USUAL. THE INFORMATION PROVIDED DOES NOT CONFIRM REPLACEMENT OF THE TUBE WAS PERFORMED BUT DID CONFIRM NO PT HARM. PRE-TEST WAS DONE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    31620 MALLINCKRODT TAPERGUARD ORAL/NASAL TRACHEAL TUBE BTR COVIDIEN, FORMERLY TYCOHEALTHCARE

    Patients

    Seq Age Sex Outcome Treatment
    1