BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RUSCH ENDOTRACHEAL TUBE, SAFETY CLEAR, 7.5 MM

    MDR report key: 2062361 · Received March 18, 2011

    Report

    Report Number
    8040412-2011-00030
    Event Type
    Malfunction
    Date Received
    March 18, 2011
    Date of Event
    February 13, 2011
    Report Date
    February 22, 2011
    Manufacturer
    TELEFLEX MEDICAL
    Product Code
    BTR
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHARMACIST

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT WILL NOT BE AVAILABLE FOR EVALUATION BY MANUFACTURER. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN INVESTIGATION IS COMPLETE.

    Description of Event or Problem · 1

    THE EVENT IS REPORTED AS: AFTER INTUBATION, THERE WAS A LEAK NOISE AND A VENTILATOR ALARM. THE NURSE TRIED TO INFLATE THE CUFF AGAIN, BUT IT WAS IMPOSSIBLE. THE DEVICE WAS REMOVED AND THE PATIENT WAS IMMEDIATELY INTUBATED AGAIN SUCCESSFULLY. NO INJURIES REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RUSCH ENDOTRACHEAL TUBE, SAFETY CLEAR, 7.5 MM ENDOTRACHEAL TUBE BTR TELEFLEX MEDICAL NA 10AG05

    Patients

    Seq Age Sex Outcome Treatment
    1