BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RUSCH SAFETY CLEAR PLUS ENDOTRACHEAL TUBE

    MDR report key: 2052115 · Received March 1, 2011

    Report

    Report Number
    8040412-2011-00021
    Event Type
    Malfunction
    Date Received
    March 1, 2011
    Report Date
    February 8, 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

    THE RESULTS OF THE INVESTIGATION ARE NOT AVAILABLE AT THE TIME OF THIS REPORT.

    Description of Event or Problem · 1

    THE EVENT IS REPORTED AS: FIFTEEN DAYS AFTER THE DEVICE WAS INSERTED, THE CUFF WAS FOUND DEFLATED. THE NURSE TRIED TO RE-INFLATE THE CUFF BUT IT WAS IMPOSSIBLE. THE PATIENT WAS RE-INTUBATED SUCCESSFULLY. IT IS REPORTED THAT THE PATIENT IS IN FINE CONDITION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RUSCH SAFETY CLEAR PLUS ENDOTRACHEAL TUBE ENDOBRONCHIAL TUBE BTR TELEFLEX MEDICAL NA 10BE09

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK