BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SHILEY

    MDR report key: 2940623 · Received January 30, 2013

    Report

    Report Number
    2936999-2013-00028
    Event Type
    Injury
    Date Received
    January 30, 2013
    Date of Event
    January 1, 2013
    Report Date
    January 4, 2013
    Manufacturer
    COVIDIEN, FORMERLY TYCOHEALTHCARE
    Product Code
    JOH
    PMA / PMN Number
    K962173
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    CUSTOMER REPORTED THAT THE INNER CANNULA OF TRACHEOSTOMY TUBE (LPC SIZE 6.0) DOES NOT LOCK SECURELY. TUBE REPLACED WITH SAME ISSUE OCCURRING ON SECOND TUBE. XREF MFR# 2936999-2013-00029.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    40819 SHILEY LOW PRESSURE CUFFED TRACH TUBE LOW JOH COVIDIEN, FORMERLY TYCOHEALTHCARE

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention