BEUDAMED
    FDA Adverse Event Summary report: N

    SHILEY

    MDR report key: 3795500 · Received April 25, 2014

    Report

    Report Number
    2936999-2014-00366
    Date Received
    April 25, 2014
    Date of Event
    January 20, 2014
    Report Date
    April 23, 2014
    Manufacturer
    COVIDIEN
    Product Code
    JOH
    PMA / PMN Number
    K962173
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    COVIDIEN CTS REFERENCE# (B)(4). INVESTIGATION PENDING RECEIPT OF SAMPLE FOR ANALYSIS. IF SAMPLE IS REC'D A SUMMARY OF THE INVESTIGATION WILL BE PROVIDED IN A SUPPLEMENTAL REPORT. REFERENCING RELATED MEDWATCH REPORT 2936999-2014-00367 AND 2936999-2014-00206.

    Description of Event or Problem · 1

    HOLD CJC. CUSTOMER REPORTED THE INNER CANNULA WOULD NOT FIT OR LOCK IN CORRECTLY. FAILURE WAS DETECTED PRIOR TO USE, THEREFORE EXTUBATION AND REINTUBATION OF A REPLACEMENT TUBE WAS NOT REQUIRED. CUSTOMER CONFIRMED THERE WAS NO PT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    250324 SHILEY CUFFLESS TRACH TUBE JOH COVIDIEN 13D0860JZX

    Patients

    Seq Age Sex Outcome Treatment
    1