BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BIVONA® UNCUFFED PEDIATRIC FLEX TEND PLUS¿ STANDARD TRACHEOSTOMY TUBE

    MDR report key: 7546715 · Received May 25, 2018

    Report

    Report Number
    3012307300-2018-01738
    Event Type
    Malfunction
    Date Received
    May 25, 2018
    Date of Event
    March 19, 2018
    Report Date
    September 28, 2018
    Manufacturer
    SMITHS MEDICAL ASD, INC.
    Product Code
    JOH
    UDI-DI
    15021312516791
    PMA / PMN Number
    K944178
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    K083641.

    Additional Manufacturer Narrative · 1

    TWO 4.5MM FLEXTEND PEDIATRIC STANDARD STRAIGHT TRACH TUBE SAMPLES WERE RECEIVED WITHOUT THEIR ORIGINAL PACKAGING INSIDE A ZIPLOC BAG. THE SAMPLES WERE IN USED CONDITION. VISUAL INSPECTION WAS PERFORMED AT 12" UNDER NORMAL CONDITIONS OF ILLUMINATION IN ORDER TO DETECT ANY DAMAGE ON THE PART. DURING THE VISUAL INSPECTION, IT WAS OBSERVED THAT THERE WERE EXPOSED WIRES IN SHAFT OF BOTH SAMPLES. AFTER A REVIEW OF THE DIFFERENT VERIFICATIONS THAT ARE PERFORMED DURING THE MANUFACTURING PROCESS TO DETECT DAMAGE COMPONENTS, THE MOST PROBABLE ROOT CAUSE IS THAT DAMAGED OCCURRED AFTER THE PRODUCT LEFT THE SHM FACILITY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT LESS THAN A WEEK AFTER PLACEMENT, THE WIRE OF THE TRACHEOSTOMY TUBE BECAME EXPOSED. THE PATIENT WAS NOTED AS BEING ACTIVE, AND THE TRACHEOSTOMY TUBE WILL OCCASIONALLY TWIST BECAUSE OF THIS. THE REPORTER SUSPECTED THE WIRE EXPOSURE WAS DUE TO THE TWISTING. NO INJURY WAS REPORTED, THE FAULT WAS NOTICED UPON REMOVAL OF THE TRACHEOSTOMY TUBE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    388255 BIVONA® UNCUFFED PEDIATRIC FLEX TEND PLUS¿ STANDARD TRACHEOSTOMY TUBE TUBE TRACHEOSTOMY AND TUBE CUFF JOH SMITHS MEDICAL ASD, INC. 3450429 15021312516791

    Patients

    Seq Age Sex Outcome Treatment
    1 27 MO