BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BIVONA CUSTOM TRACHEOSTOMY TUBE

    MDR report key: 1952414 · Received January 3, 2011

    Report

    Report Number
    2183502-2010-00643
    Event Type
    Malfunction
    Date Received
    January 3, 2011
    Date of Event
    December 2, 2010
    Report Date
    December 30, 2010
    Manufacturer
    SMITHS MEDICAL ASD, INC
    Product Code
    JOH
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL MANUFACTURER NARRATIVE: CUSTOMER HAS NOT YET RETURNED THE DEVICE TO THE MANUFACTURER FOR DEVICE EVALUATION. WHEN AND IF THE DEVICE BECOMES AVAILABLE AND IS RETURNED AND EVALUATED, THE MANUFACTURER WILL FILE A FOLLOW-UP REPORT DETAILING THE RESULTS OF THE EVALUATION.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT ALLEGES THE TRACHEOSTOMY TUBE WAS DEFLATING AT THE CUFF AFTER SEVERAL DAYS IN SITU. REPLACEMENT WAS REQUIRED. NO INCIDENT RELATED MEDICAL SEQUELA WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BIVONA CUSTOM TRACHEOSTOMY TUBE JOH - TRACHEOSTOMY TUBE JOH SMITHS MEDICAL ASD, INC NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK