BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SHILEY DISPOSABLE CANNULA

    MDR report key: 2881451 · Received December 17, 2012

    Report

    Report Number
    2936999-2012-00666
    Event Type
    Injury
    Date Received
    December 17, 2012
    Date of Event
    November 1, 2012
    Report Date
    November 19, 2012
    Manufacturer
    HENEQUEN - RX, AVENDIA HENEQUEN
    Product Code
    JOH
    PMA / PMN Number
    K962173
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE CALLER INDICATED THAT THE SAMPLE ASSOCIATED TO THIS REPORT IS EXPECTED TO BE RETURNED TO THE MANUFACTURING SITE FOR ANALYSIS BUT HAS YET TO BE RECEIVED. IF THE SAMPLE IS RECEIVED A SUMMARY OF THE SAMPLE ANALYSIS WILL BE PROVIDED IN A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    THE CALLER REPORTED AN 8DCT TRACHEOSTOMY TUBES DEFLATED DUE TO CUFF LEAKS. THE VENTILATOR WAS (B)(4), BUT THE CALLER WAS NOT CERTAIN OF THE SETTINGS. SHE THOUGHT THE TRACHEOSTOMY TUBE WAS PRETESTED. SHE IS NOT AWARE OF HOW THE TUBE WAS IN BEFORE FAILURE, THE PATIENT HAS NO KNOWN ANATOMY ANOMALIES THAT WOULD CAUSE THE PROBLEM WITH THE CUFFS. SHE WAS NOT CERTAIN OF THE CUFF PRESSURE BEING USED NOR OF ANY LUBRICANT BEING USED. THE PATIENT WAS RE-INTUBATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SHILEY DISPOSABLE CANNULA TRACHEOSTOMY TUBE JOH HENEQUEN - RX, AVENDIA HENEQUEN

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention