BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SHILEY

    MDR report key: 3421968 · Received October 15, 2013

    Report

    Report Number
    2936999-2013-00776
    Event Type
    Injury
    Date Received
    October 15, 2013
    Date of Event
    September 19, 2013
    Report Date
    September 20, 2013
    Manufacturer
    COVIDIEN
    Product Code
    JOH
    PMA / PMN Number
    K962173
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PO
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). COVIDIEN IS IN THE PROCESS OF OBTAINING FURTHER INFORMATION SURROUNDING THE CIRCUMSTANCES OF THIS REPORT. IF FURTHER INFORMATION BECOMES AVAILABLE, A SUPPLEMENTAL REPORT WILL BE PROVIDED. WE ARE UNABLE TO DETERMINE THE EXACT CAUSE FOR THIS SPECIFIC EVENT. HOWEVER, MANUFACTURING CONTROLS ARE IN PLACE TO DETECT RELATED ISSUES AND TO REDUCE THE POTENTIAL FOR OCCURRENCE DURING THE MANUFACTURING PROCESS. INFORMATION OF THIS NATURE IS INCLUDED IN OUR DATABASE AND MONITORED THROUGH TRENDING.

    Description of Event or Problem · 1

    CUSTOMER REPORTED THAT THE TRACHEOSTOMY TUBE CUFF WAS RUPTURED NEXT TO THE GUIDE WIRE. COVIDIEN IS ATTEMPTING TO GATHER FURTHER DETAILS SURROUNDING THE CIRCUMSTANCES OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    527265 SHILEY LOW PRESSURE CUFFED TRACH TUBE JOH COVIDIEN 12H0148JZX

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention