BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MALLINCKRODT

    MDR report key: 2100464 · Received May 17, 2011

    Report

    Report Number
    2936999-2011-00329
    Event Type
    Injury
    Date Received
    May 17, 2011
    Date of Event
    April 1, 2011
    Report Date
    April 18, 2011
    Manufacturer
    COVIDIEN, FORMERLY TYCOHEALTHCARE
    Product Code
    BTR
    PMA / PMN Number
    K871204
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE SAMPLE IS NOT EXPECTED TO BE RETURNED. ADDITIONALLY, THE LOT # ASSOCIATED TO THE DEVICE HAS NOT MADE AVAILABLE FOR A LOT HISTORY REVIEW. WITHOUT THE SAMPLE, THE REPORTED COMPLAINT CANNOT BE INVESTIGATED AND/OR CONFIRMED. IT THE SAMPLE IS RETURNED AT A LATER DATE, A SAMPLE ANALYSIS WILL BE PERFORMED AND IF ANY SIGNIFICANT INFO IS IDENTIFIED, A SUMMARY OF THE ANALYSIS WILL BE PROVIDED IN A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    THE COMPANY RECEIVED A REPORT WHERE IT WAS CLAIMED THAT THE END CLINICIAN EXPERIENCED DIFFICULTY PASSING A SUCTION CATHETER DOWN THE TUBE. THE CALLER REPORTED THIS OCCURRED DUE TO THE TUBE DEVELOPING A KINK. THIS REPORT IS ASSOCIATED TO INFO PROVIDED ON (B)(4)/ MFR # 2936999-2011-00328 WHERE IT WAS CLAIMED THAT A PREVIOUS EVENT OCCURRED OF THE SAME ISSUE. NO INFO WAS PROVIDED IN DETAIL BUT IT WAS SUGGESTED THE TUBE FAILED IN THE SAME MANNER. FURTHER INFO IS PENDING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MALLINCKRODT LO-PRO MURPHY TRACHEAL TUBE BTR COVIDIEN, FORMERLY TYCOHEALTHCARE

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention