BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SHILEY

    MDR report key: 3760792 · Received April 8, 2014

    Report

    Report Number
    2936999-2014-00317
    Event Type
    Injury
    Date Received
    April 8, 2014
    Date of Event
    March 4, 2014
    Report Date
    March 10, 2014
    Manufacturer
    COVIDIEN
    Product Code
    JOH
    PMA / PMN Number
    K955680
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THIS COMPLAINT IS RELATED TO FILES (B)(4), WHERE A NONCONFORMANCE INVESTIGATION WAS PERFORMED FOR (B)(4) WHERE ON ONE RETURNED SAMPLE OF A SHILEY PEDIATRIC TRACHEOSTOMY TUBE WAS RECEIVED FOR EVALUATION. NO ANALYSIS OF THE ACTUAL DEVICES WAS PERFORMED FOR COMPLAINTS (B)(4), BECAUSE THE SAMPLES HAVE NOT BEEN RECEIVED FOR EVALUATION TO CONFIRM THE FAILURE. THE LOT NUMBERS WERE PROVIDED. (B)(4). NO NONCONFORMITIES REPORTS RELATED TO THE FAILURE MODE REPORTED WERE FOUND. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4). NO SAMPLE IS EXPECTED TO BE RETURNED. WITHOUT THE ACTUAL COMPLAINT SAMPLE A FULL INVESTIGATION CANNOT BE COMPLETED; THEREFORE, WE ARE UNABLE TO DETERMINE THE CAUSE FOR THIS SPECIFIC EVENT; HOWEVER, MANUFACTURING CONTROLS ARE IN PLACE TO DETECT RELATED ISSUES AND TO REDUCE THE POTENTIAL FOR OCCURRENCE DURING THE MFG PROCESS. INFO OF THIS NATURE IS INCLUDED IN OUR DATABASE AND MONITORED THROUGH TRENDING. (B)(4).

    Description of Event or Problem · 1

    CALLER REPORTED THE TRACHEAL TUBE HAD A LEAK FROM THIS CUFF. CUSTOMER CONFIRMED THAT NO FAULT WAS IDENTIFIED DURING PRETESTING EFFORTS. THE INFO PROVIDED SUGGEST THAT DECANNULATION AND RECANNULATION OF A REPLACEMENT TUBE WAS REQUIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    210216 SHILEY CUFFED PEDIATRIC TRACH TUBE JOH COVIDIEN 13G070212X

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention