BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SHILEY LOW PRESSURE CUFFED

    MDR report key: 1844855 · Received September 22, 2010

    Report

    Report Number
    2936999-2010-01212
    Event Type
    Malfunction
    Date Received
    September 22, 2010
    Date of Event
    August 1, 2010
    Report Date
    August 24, 2010
    Manufacturer
    COVIDIEN/FORMERLY TYCO HEALTHCARE
    Product Code
    JOH
    PMA / PMN Number
    K962173
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE HISTORY RECORD FOR THE LOT NUMBER PROVIDED WILL BE REVIEWED. IF THE SAMPLE IS RETURNED, A FAILURE INVESTIGATION WILL BE PERFORMED.

    Description of Event or Problem · 1

    THE CALLER STATED THAT IT WAS REPORTED THAT THERE WAS LEAKAGE OF AIR AT THE INNER CANNULA/OUTER CANNULA CONNECTION. THE CALLER SAID NO PATIENT HARM WAS REPORTED BUT HE COULD NOT CONFIRM IF THERE WAS A RECANNULATION OF THE PATIENT DUE TO NO FURTHER INFORMATION PROVIDED BY THE HOSPITAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SHILEY LOW PRESSURE CUFFED TRACHEOSTOMY TUBE JOH COVIDIEN/FORMERLY TYCO HEALTHCARE 10060000376

    Patients

    Seq Age Sex Outcome Treatment
    1