BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HUDSON SHERIDAN/HVT ET TUBE, 6.5

    MDR report key: 2864479 · Received December 6, 2012

    Report

    Report Number
    3003898360-2012-00564
    Event Type
    Malfunction
    Date Received
    December 6, 2012
    Date of Event
    November 19, 2012
    Report Date
    November 26, 2012
    Manufacturer
    TELEFLEX MEDICAL
    Product Code
    BTR
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE SAMPLE WAS NOT RETURNED FOR EVALUATION AT THE TIME OF THIS REPORT. A VISUAL INSPECTION WAS CONDUCTED FROM THE PHOTO RECEIVED. FROM THE PHOTO IT WAS OBSERVED THAT THE PACKAGE IS BROKEN. NO OTHER DEFECTS WERE OBSERVED. A DEVICE HISTORY RECORD (DHR) REVIEW WAS CONDUCTED ON THE REPORTED LOT NUMBER. THE DHR INVESTIGATION DID NOT SHOW ISSUES RELATED TO THE COMPLAINT. A CONCLUSIVE ROOT CAUSE CAN NOT BE DETERMINED SINCE THE SAMPLE WAS NOT AVAILABLE AT THE TIME OF THIS REPORT. TELEFLEX WILL CONTINUE TO MONITOR AND TREND RELATING COMPLAINTS.

    Description of Event or Problem · 1

    THE EVENT IS REPORTED AS: THE PACKAGE IS TORN/BROKEN. NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HUDSON SHERIDAN/HVT ET TUBE, 6.5 ENDOTRACHEAL TUBE BTR TELEFLEX MEDICAL 01C1200073

    Patients

    Seq Age Sex Outcome Treatment
    1