BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PORTEX® BIVONA® AIRE-CUF® ADULT TRACHEOSTOMY TUBES

    MDR report key: 5921094 · Received September 1, 2016

    Report

    Report Number
    2183502-2016-01866
    Event Type
    Malfunction
    Date Received
    September 1, 2016
    Report Date
    August 4, 2016
    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

    THE 510(K): K912967 AND K083641. CUSTOMER HAS NOT RETURNED THE DEVICE TO THE MANUFACTURER FOR DEVICE EVALUATION. IF THE DEVICE BECOMES AVAILABLE AND IS RETURNED AND EVALUATED, THE MANUFACTURER WILL FILE A FOLLOW-UP REPORT DETAILING THE RESULTS OF THE EVALUATION.

    Additional Manufacturer Narrative · 1

    ONE UNUSED BIVONA® AIRE-CUF® ADULT TRACHEOSTOMY TUBE WAS RETURNED FOR EVALUATION. VISUAL INSPECTION AND DIMENSIONAL ANALYSIS DID NOT FIND ANY NON-CONFORMITIES. FUNCTIONAL TESTING INVOLVED PERFORMING A SUCTION CATHETER TEST AND DID NOT FIND ANY NON-CONFORMITIES. THE DEVICE WAS FOUND TO MEET MANUFACTURING SPECIFICATIONS. BASED ON THE EVIDENCE, THE COMPLAINT WAS UNABLE TO BE CONFIRMED. THERE WAS NO EVIDENCE FOUND TO SUGGEST THE EVENT WAS CAUSED FROM AN INTRINSIC DEFECT IN THE PRODUCT. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT BIVONA AIRE-CUF ADULT TRACHEOSTOMY TUBES HAD POOR VENTILATION. THEY WERE IN USE WITH PATIENT AND ATTACHED VENTILATOR ALARMED "HIGH PRESSURE." THE CAREGIVER ATTEMPTED TO SUCTION THE TRACHEOSTOMY TUBE BUT SUCTIONING THE TUBE WAS DIFFICULT RELATED TO AN OBSTRUCTION. INTRODUCING THE ASPIRATION TUBE WAS DIFFICULT AND THERE WAS NOTHING TO ASPIRATE. NO PERMANENT INJURY REPORTED. SEE MFR: 2183502-2016-01867.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    573701 PORTEX® BIVONA® AIRE-CUF® ADULT TRACHEOSTOMY TUBES TUBE TRACHEOSTOMY AND TUBE CUFF JOH SMITHS MEDICAL ASD INC. 2967770

    Patients

    Seq Age Sex Outcome Treatment
    1