BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BIVONA MID-RANGE TRACHEOSTOMY TUBE WITH AIRE-CUF

    MDR report key: 1942778 · Received December 20, 2010

    Report

    Report Number
    2183502-2010-00601
    Event Type
    Malfunction
    Date Received
    December 20, 2010
    Report Date
    December 19, 2010
    Manufacturer
    SMITHS MEDICAL ASD, INC.,
    Product Code
    JOH
    PMA / PMN Number
    K913859
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    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 THAT THE TRACHEOSTOMY TUBE WAS DEFLATING AT THE CUFF AFTER 3 HOURS 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 MID-RANGE TRACHEOSTOMY TUBE WITH AIRE-CUF TRACHEOSTOMY TUBE JOH SMITHS MEDICAL ASD, INC., NA 1331951

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK