BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SHILEY LOW PRESSURE CUFFED

    MDR report key: 1821487 · Received August 25, 2010

    Report

    Report Number
    2936999-2010-01131
    Event Type
    Injury
    Date Received
    August 25, 2010
    Date of Event
    July 1, 2010
    Report Date
    July 26, 2010
    Manufacturer
    COVIDIEN, FORMERLY TYCO HEATLHCARE
    Product Code
    JOH
    PMA / PMN Number
    K962173
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, 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 REPORTED THAT THE TUBE SEPARATED FROM THE HUB AFTER 2 HOURS OF USE. THIS REQUIRED RECANNULATION WITH ANOTHER 4LPC THAT WAS NOT PART OF ROUTINE TRACH CHANGING. THE PT TOLERATED THE RECANNULATION WELL, AND THERE WERE NO OTHER DETAILS ABOUT THE RECANNULATION THAT THE CALLER COULD PROVIDE. THE TRACH DID NOT HAVE AN EXP DATE AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SHILEY LOW PRESSURE CUFFED TRACHEOSTOMY TUBE JOH COVIDIEN, FORMERLY TYCO HEATLHCARE 1002001403

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention