BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SHILEY LOW PRESSURE CUFFED

    MDR report key: 2040952 · Received March 25, 2011

    Report

    Report Number
    2936999-2011-00230
    Event Type
    Injury
    Date Received
    March 25, 2011
    Date of Event
    March 1, 2011
    Report Date
    March 2, 2011
    Manufacturer
    COVIDIEN/FORMERLY TYCO HE
    Product Code
    JOH
    PMA / PMN Number
    K962173
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE LOT NUMBER IS UNKNOWN THEREFORE THE DATE OF MANUFACTURE CAN NOT BE DETERMINED. NO ANALYSIS OR CONCLUSIONS CAN BE MADE WITH OUT THE DEVICE. INFORMATION HAS BEEN ADDED TO THE DATABASE FOR TRENDING PURPOSES.

    Description of Event or Problem · 1

    THE CALLER STATED THAT HER PATIENT'S 6LPC TRACHEOSTOMY TUBE'S CUFF WOULD NOT HOLD AIR. THE TUBE WAS IN USE FOR TWO WEEKS. THE LEAK IN THE CUFF REQUIRED RECANNULATION WITH ANOTHER 6LPC THAT WAS NOT A PART OF ROUTINE TRACH CHANGING. THE SPOT OF THE LEAK WAS NOT ISOLATED. THE CALLER STATED THAT THE CUFFS ON THIS PATIENT'S TUBES ARE NOT PRE-TESTED AND THEY ARE INFLATED WITH 10-15 CC S. THE TUBES THROWN AWAY, AND NO LOT OR EXPIRATION DATE IS AVAILABLE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention