BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RUSCH TFX ISIS SUBGLOTTIC SEC. ETT, 7.5

    MDR report key: 6093363 · Received November 10, 2016

    Report

    Report Number
    3003898360-2016-01029
    Event Type
    Malfunction
    Date Received
    November 10, 2016
    Date of Event
    October 26, 2016
    Report Date
    October 28, 2016
    Manufacturer
    TELEFLEX MEDICAL
    Product Code
    BTR
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). ADDITIONAL INFORMATION WAS REQUESTED IN REGARDS TO THE ORIGINAL REPORT INDICATING POSSIBILITY OF PATIENT RE-INTUBATION. THE CUSTOMER WAS NOT ABLE TO CONFIRM THIS. CUSTOMER REPORTED NO INJURY TO PATIENT. A VISUAL, FUNCTIONAL AND DIMENSIONAL INSPECTION OF THE DEVICE INVOLVED IN THE COMPLAINT COULD NOT BE CONDUCTED SINCE THE DEVICE WAS NOT RETURNED. A DEVICE HISTORY RECORD REVIEW COULD NOT BE CONDUCTED SINCE THE LOT NUMBER WAS NOT PROVIDED. CORRECTIVE ACTIONS CANNOT BE ESTABLISHED SINCE IT IS NECESSARY TO RECEIVE THE DEVICE SAMPLE TO PERFORM A PROPER INVESTIGATION AND CONFIRM THE ALLEGED DEFECT. CUSTOMER COMPLAINT CANNOT BE CONFIRMED. THE ROOT CAUSE IS UNKNOWN.

    Description of Event or Problem · 1

    CUSTOMER COMPLAINT ALLEGES THAT "PHYSICIANS WITHIN THE ICU STATED THEY NOTICED THE CUFF TORN".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    745361 RUSCH TFX ISIS SUBGLOTTIC SEC. ETT, 7.5 TRACHEAL TUBE BTR TELEFLEX MEDICAL UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1