BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HUDSON/SHERIDAN ENDOTRACHEAL TUBE, HVT, 7.0

    MDR report key: 2802496 · Received October 18, 2012

    Report

    Report Number
    3003898360-2012-00478
    Event Type
    Malfunction
    Date Received
    October 18, 2012
    Date of Event
    September 1, 2012
    Report Date
    September 26, 2012
    Manufacturer
    TELEFLEX MEDICAL
    Product Code
    BTR
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WV, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE SAMPLE WAS RETURNED FOR EVALUATION. THE DEVICE HISTORY RECORD, (DHR) REVIEW WAS CONDUCTED FOR THE REPORTED LOT NUMBER. THE DHR INVESTIGATION DID NOT SHOW ISSUES RELATED TO THE COMPLAINT.

    Description of Event or Problem · 1

    THE EVENT IS REPORTED AS: THE TUBE WOULD NOT DEFLATE AND WAS NOT USED ON A PT. NO REPORT OF PT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HUDSON/SHERIDAN ENDOTRACHEAL TUBE, HVT, 7.0 EDOTRACHEAL TUBE BTR TELEFLEX MEDICAL 01F1200281

    Patients

    Seq Age Sex Outcome Treatment
    1