BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PORTEX® BIVONA® AIRE-CUF® NEONATAL AND PEDIATRIC TRACHEOSTOMY TUBE

    MDR report key: 6439277 · Received March 28, 2017

    Report

    Report Number
    3012307300-2017-00767
    Event Type
    Malfunction
    Date Received
    March 28, 2017
    Date of Event
    March 1, 2017
    Report Date
    May 5, 2017
    Manufacturer
    SMITHS MEDICAL ASD, INC.
    Product Code
    JOH
    UDI-DI
    15021312000290
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    EVENT DATE: (B)(6) 2017. PMA/510(K) NUMBER: K944178 AND K083641. SMITHS MEDICAL HAS RECEIVED THE SAMPLE DEVICE. A FULL EVALUATION IS ANTICIPATED, BUT NOT YET BEGUN AS THE DEVICE IS CURRENTLY IN TRANSIT TO THE INVESTIGATION SITE.

    Additional Manufacturer Narrative · 1

    ONE BIVONA® 3.5MM AIRE-CUF® NEONATAL AND PEDIATRIC TRACHEOSTOMY TUBE WAS RETURNED FOR INVESTIGATION. DURING FUNCTIONAL TESTING, A SYRINGE WAS USED TO INFLATE THE DEVICE CUFF AND INFLATION BALLOON WITH 5CC'S OF AIR AND THE DEVICE WAS SUBMERGED UNDER WATER; THE DEVICE WAS MANIPULATED WHILE UNDER THE WATER. NO BUBBLES (INDICATING A LEAK) WERE FOUND ESCAPING FROM THE DEVICE. THE CUFF WAS REMOVED FROM THE WATER AND THE DEVICE CUFF WAS INFLATED WITH 5CC'S OF AIR AND ALLOWED TO SIT FOR 4 HOURS. A LOSS OF VOLUME OF THE CUFF WAS OBSERVED; HOWEVER, A LEAK COULD NOT BE DETECTED. INVESTIGATION WAS UNABLE TO DETERMINE THE ROOT CAUSE OF THE REPORTED ISSUE; HOWEVER, NO EVIDENCE WAS FOUND TO SUGGEST A MANUFACTURING DEFECT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PORTEX® BIVONA® AIRE-CUF® NEONATAL AND PEDIATRIC TRACHEOSTOMY TUBE AIR IN THE CUFF DECREASED TO HALF-CAPACITY 6 HOURS AFTER INITIAL USE WITH A PATIENT. THE ISSUE WAS OBSERVED BY MEDICAL PERSONNEL. IT WAS UNKNOWN IF THE TUBE HAD BEEN CHECKED PRIOR TO USE. THE TRACHEOSTOMY TUBE WAS REPLACED WITH A NEW ONE. NO PATIENT INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    223428 PORTEX® BIVONA® AIRE-CUF® NEONATAL AND PEDIATRIC TRACHEOSTOMY TUBE TUBE TRACHEOSTOMY AND TUBE CUFF JOH SMITHS MEDICAL ASD, INC. 15021312000290

    Patients

    Seq Age Sex Outcome Treatment
    1