BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SHILEY

    MDR report key: 2860394 · Received December 4, 2012

    Report

    Report Number
    2936999-2012-00635
    Event Type
    Injury
    Date Received
    December 4, 2012
    Date of Event
    November 5, 2012
    Report Date
    November 5, 2012
    Manufacturer
    COVIDIEN, FORMERLY TYCOHEALTH
    Product Code
    JOH
    PMA / PMN Number
    K962173
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE SAMPLE IS CURRENTLY IN TRANSIT TO THE MFG SITE FOR ANALYSIS.

    Description of Event or Problem · 1

    CALLER STATES THAT THE TUBE WOULD NOT HOLD AIR AFTER TWO HOURS OF PT USE. CALLER COULD NOT CONFIRM THE SOURCE OF THE LEAK. CALLER CONFIRMED THAT THE TUBE WAS PRETESTED. A LOT # WAS PROVIDED. CALLER CONFIRMED THE EXTUBATION AND RECANNULATION OF A REPLACEMENT TUBE WAS REQUIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SHILEY DISPOSABLE CANNULA LOW PRESSURE JOH COVIDIEN, FORMERLY TYCOHEALTH 081002433

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention