BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BIVONA UNCUFFED PEDIATRIC FLEX TEND PLUS TRACHEOSTOMY TUBE

    MDR report key: 3252707 · Received July 15, 2013

    Report

    Report Number
    2183502-2013-00383
    Event Type
    Malfunction
    Date Received
    July 15, 2013
    Date of Event
    May 30, 2013
    Report Date
    July 12, 2013
    Manufacturer
    SMITHS MEDICAL ASD, INC.
    Product Code
    JOH
    PMA / PMN Number
    K944178
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    NURSE

    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 F/U REPORT DETAILING THE RESULTS OF THE EVAL.

    Description of Event or Problem · 1

    USER FACILITY REPORTED THAT THE DEVICE WAS IN USE WITH PT (TIME IN USE NOT PROVIDED). ACCORDING TO REPORT, THE DEVICE WAS BEING REMOVED FROM USE DURING SCHEDULED TRACHEOSTOMY TUBE CHANGE AND IT WAS NOTED THAT THE RIGHT SIDE FLANGE HAD BROKEN OFF. NO ADVERSE EFFECTS TO PT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    327539 BIVONA UNCUFFED PEDIATRIC FLEX TEND PLUS TRACHEOSTOMY TUBE JOH - TRACHEOSTOMY TUBE JOH SMITHS MEDICAL ASD, INC. NA 2328520

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK