BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MALLINKCRODT

    MDR report key: 1858740 · Received September 30, 2010

    Report

    Report Number
    2936999-2010-01235
    Event Type
    Injury
    Date Received
    September 30, 2010
    Date of Event
    September 1, 2010
    Report Date
    September 1, 2010
    Manufacturer
    COVIDIEN, FORMERLY TYCOHEALTHCARE
    Product Code
    BTS
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). APPLICABLE 510K # FOR U.S. DISTRIBUTED PART IS K771219. THE SAMPLE ASSOCIATED TO THIS REPORT IS NOT EXPECTED TO BE RETURNED FOR ANALYSIS. THE CUSTOMER DID PROVIDE A LOT #. MANUFACTURING WILL PERFORM A LOT HISTORY REVIEW OF THE REPORTED LOT AS PART OF THE INVESTIGATION. IF SIGNIFICANT INFORMATION IS IDENTIFIED FROM THE LOT REVIEW THEN A SUMMARY OF THE FINDINGS WILL BE PROVIDED IN A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    THE COMPANY RECEIVED A REPORT WHERE IT WAS CLAIMED THAT THE TUBE RIPPED AT THE CUFF DURING PATIENT USE. THE CALLER REPORTED THREE OCCURRENCES ON ONE PATIENT WHERE EXTUBATION AND REINTUBATION OF A REPLACEMENT TUBE WAS REQUIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MALLINKCRODT BRONCHO-CATH ENDOBRONCHIAL TUBE BTS COVIDIEN, FORMERLY TYCOHEALTHCARE 2010017085

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention