BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SHILEY

    MDR report key: 3082571 · Received April 24, 2013

    Report

    Report Number
    2936999-2013-00315
    Event Type
    Malfunction
    Date Received
    April 24, 2013
    Date of Event
    September 30, 2012
    Report Date
    March 25, 2013
    Manufacturer
    COVIDIEN
    Product Code
    JOH
    PMA / PMN Number
    K962173
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). SAMPLE IS EXPECTED TO BE RETURNED FOR ANALYSIS.

    Description of Event or Problem · 1

    CUSTOMER REPORTS THAT TUBE IS ABNORMALLY CROOKED AT THE TIP (DISTAL END THAT GOES INTO PATIENT). THIS WAS RECOGNIZED PRE-INSERTION. NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    176217 SHILEY DISPOSABLE CANNULA LOW PRESSURE CUFFED JOH COVIDIEN 120201968X

    Patients

    Seq Age Sex Outcome Treatment
    1