BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BIVONA TTS CUFF PEDIATRIC TRACHEOSTOMY TUBE

    MDR report key: 3862999 · Received June 5, 2014

    Report

    Report Number
    2183502-2014-00377
    Event Type
    Injury
    Date Received
    June 5, 2014
    Report Date
    June 4, 2014
    Manufacturer
    SMITHS MEDICAL ASD
    Product Code
    JOH
    PMA / PMN Number
    K914088
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    MANUFACTURER COMPLETED THE ENTIRE FORM. 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 AND FOLLOW-UP REPORT DETAILING THE RESULTS OF THE EVALUATION. (B)(4).

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED STATING THAT MINUTES AFTER PLACING THE LISTED TRACHEOSTOMY TUBE INTO USE WITH PATIENT THE VENTILATOR IN USE ALARMED "LOW PRESSURE" AND A SIGNIFICANT AMOUNT OF AIR WAS FOUND ESCAPING FROM THE PATIENT'S STOMA. THE TUBE WAS IMMEDIATELY EXCHANGE REPORTEDLY INSPECTED THE REMOVED TUBE TO FIND THAT THE CUFF COULD NOT REMAIN INFLATED. THE RN REPORTED THAT THE PATIENT'S OXYGEN SATURATION LEVELS REMAINED STABLE THROUGHOUT THE EVENT. NO INCIDENT RELATED MEDICAL SEQUELA WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    329068 BIVONA TTS CUFF PEDIATRIC TRACHEOSTOMY TUBE TUBE TRACHEOSTOMY AND TUBE CUFF JOH SMITHS MEDICAL ASD NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention