BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SHILEY LOW PRESSURE CUFFED

    MDR report key: 1884921 · Received October 21, 2010

    Report

    Report Number
    2936999-2010-01223
    Event Type
    Injury
    Date Received
    October 21, 2010
    Date of Event
    September 1, 2010
    Report Date
    September 27, 2010
    Manufacturer
    COVIDIEN/FORMERLY TYCO
    Product Code
    JOH
    PMA / PMN Number
    K962173
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE LOT NUMBER IS UNKNOWN AND THEREFORE, THE DATE OF MANUFACTURE CANNOT BE DETERMINED. THE TUBE WAS DISCARDED AND THEREFORE, UNAVAILABLE FOR FAILURE INVESTIGATION. NO ANALYSIS OR CONCLUSIONS CAN BE DRAWN.

    Description of Event or Problem · 1

    THE CALLER STATED THAT THE CUFF ON THE TRACHEOSTOMY TUBE WOULD NOT STAY INFLATED. THE SOURCE OF THE LEAK WAS NOT DETERMINED. THE TUBE WAS IN USE FOR ABOUT A DAY, AND THE ISSUE REQUIRED RECANNULATION OF THE PATIENT WITH THE SAME MODEL TUBE. THE CALLER STATED THE CUFFS ARE PRE-TESTED, BUT DID NOT KNOW HOW MUCH PRESSURE WAS USED TO INFLATE THE CUFF. THE PATIENT IS ON A VENTILATOR, BUT THE CALLER DID NOT KNOW THE MODEL OR HOW LONG THE PATIENT IS ON IT PER DAY. THERE IS NO LOT OR EXP DATE AVAILABLE. THE TUBE WAS THROWN AWAY AND IS NOT AVAILABLE FOR EVALUATION.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention