BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PORTEX BLUE LINE ULTRA SUCTIONAID TRACHEOSTOMY TUBE

    MDR report key: 3031261 · Received March 5, 2013

    Report

    Report Number
    2183502-2013-00060
    Event Type
    Malfunction
    Date Received
    March 5, 2013
    Date of Event
    January 24, 2013
    Report Date
    March 4, 2013
    Manufacturer
    SMITHS MEDICAL MD, INC.
    Product Code
    JOH
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IS
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    CUSTOMER HAS NOT YET RETURNED THE DEVICE TO THE MFR FOR DEVICE EVAL. WHEN AND IF THE DEVICE BECOMES AVAILABLE AND IS RETURNED AND EVALUATED THE MFR WILL FILE A FOLLOW-UP REPORT DETAILING THE RESULTS OF THE EVAL.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT ALLEGES THAT THE TRACHEOSTOMY TUBE WAS USED ON A PATIENT FOR 9 DAYS WHEN THE TRACHEAL TUBE CUFF BECAME DEFLATED. NO INCIDENT RELATED MEDICAL SEQUELAE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    94728 PORTEX BLUE LINE ULTRA SUCTIONAID TRACHEOSTOMY TUBE TRACHEOSTOMY TUBE, CLINICAL-USE, SINGLE USE JOH SMITHS MEDICAL MD, INC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK