BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PORTEX® BIVONA® AIRE-CUF® PEDIATRIC TRACHEOSTOMY TUBE

    MDR report key: 6674919 · Received June 28, 2017

    Report

    Report Number
    3012307300-2017-01387
    Event Type
    Malfunction
    Date Received
    June 28, 2017
    Date of Event
    June 8, 2017
    Report Date
    October 31, 2017
    Manufacturer
    SMITHS MEDICAL ASD, INC.
    Product Code
    JOH
    UDI-DI
    15021312005998
    PMA / PMN Number
    K944178
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ONE PHOTO WAS RETURNED FOR EVALUATION. VISUAL EVALUATION OF THE IMAGE FOUND THAT THE NECK FLANGE WAS BROKEN. ONE DEVICE WAS RETURNED FOR EVALUATION IN USED CONDITION. VISUAL INSPECTION OF THE DEVICE FOUND THAT THERE WAS A SPLIT ON THE RIGHT SIDE OF THE NECK FLANGE AND THE LEFT SIDE OF THE NECK FLANGE WAS BROKEN. A REVIEW OF THE TESTING AND INSPECTION DOCUMENTS WAS PERFORMED AND CONSIDERED ADEQUATE AND CORRECT. A REVIEW OF THE MANUFACTURING PROCESS ON A SIMILAR PART WAS PERFORMED AND FOUND NO ISSUES. A REVIEW OF 32 DEVICES WAS PERFORMED FOR MOLDING ISSUES AND FOUND NO DAMAGE. BASED ON THE EVIDENCE, A ROOT CAUSE WAS UNABLE TO BE CONFIRMED. IT WAS CONCLUDED THAT THE DAMAGE LIKELY OCCURRED OUTSIDE OF THE MANUFACTURING FACILITY.

    Additional Manufacturer Narrative · 1

    ADDITIONAL 510(K) - 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE FLANGE OF A PORTEX® BIVONA® AIRE-CUF® PEDIATRIC TRACHEOSTOMY TUBE WAS BROKEN. THE TRACHEOSTOMY TUBE HAD BEEN IN USE FOR TWO WEEKS WHEN THE FAULT OCCURRED. NO INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    454538 PORTEX® BIVONA® AIRE-CUF® PEDIATRIC TRACHEOSTOMY TUBE TUBE TRACHEOSTOMY AND TUBE CUFF JOH SMITHS MEDICAL ASD, INC. 15021312005998

    Patients

    Seq Age Sex Outcome Treatment
    1 5 YR