BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PORTEX®BIVONA® UNCUFFED NEONATAL AND PEDIATRIC TRACHEOSTOSTOMY TUBE

    MDR report key: 5756349 · Received June 28, 2016

    Report

    Report Number
    2183502-2016-01266
    Event Type
    Malfunction
    Date Received
    June 28, 2016
    Date of Event
    May 25, 2016
    Report Date
    May 31, 2016
    Manufacturer
    SMITHS MEDICAL ASD INC.,
    Product Code
    JOH
    PMA / PMN Number
    K944178
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE REPORTED TRACHEOSTOMY TUBE WAS RETURNED FOR EVALUATION. DURING VISUAL INSPECTION, TWO PORTIONS OF WIRE, MEASURING FOUR AND ELEVEN MILLIMETERS, WERE OBSERVED PROTRUDING FROM THE SURFACE OF THE DISTAL SHAFT TUBING. IN ADDITION, A FIVE MILLIMETER SECTION PROXIMAL TO THE NECK FLANGE AND A TWENTY-THREE MILLIMETER SECTION DISTAL TO THE NECK FLANGE WERE FOUND DAMAGED. A TWISTED LENGTH OF WIRE WAS ALSO OBSERVED IN THE INNER DIAMETER OF THE TUBE. ADDITIONAL TESTING OF THE DEVICE COULD NOT BE PERFORMED DUE TO THE SHAFT DAMAGE. A REVIEW OF THE DEVICE MASTER RECORDS FOR THE REPORTED PRODUCT NUMBER, FOUND NO DISCREPANCIES OR NON-CONFORMITIES DURING MANUFACTURING. INVESTIGATION AND EVALUATION COULD NOT DETERMINE THE ROOT CAUSE OF THE EXPOSED WIRE; HOWEVER, NO EVIDENCE WAS FOUND TO SUGGEST AN INTRINSIC PRODUCT PROBLEM. ADDITIONAL INFORMATION INCLUDED IN FOLLOW-UP REPORT DEVICE EVALUATION COMPLETION DATE (07/30/2016).

    Additional Manufacturer Narrative · 1

    THE DEVICE IS CURRENTLY BEING EVALUATED; THE MANUFACTURER WILL FILE A FOLLOW-UP REPORT DETAILING THE RESULTS OF THE EVALUATION ONCE IT IS COMPLETED. THE 501K NUMBERS: K944178 / K083641.

    Description of Event or Problem · 1

    THE CUSTOMER CALLED IN REPORT ON A PORTEX BIVONA UNCUFFED NEONATAL AND PEDIATRIC FLEXTEND PLUS SILICONE TRACHEOSTOMY TUBES. THE TRACHEOSTOMY TUBE WAS TAKEN OUT FOR REGULAR REPROCESSING AND THERE WAS AN OBSERVED BROKEN WIRE STICKING OUT OF SHAFT. THE PATIENT IS NOT VENTILATOR DEPENDENT AND CAN BREATHE WITHOUT THE TUBE IN PLACE. CUFF PATENCY WAS NOT TESTED PRIOR TO USE. THE PATIENTS CONDITION IS UNKNOWN AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    411698 PORTEX®BIVONA® UNCUFFED NEONATAL AND PEDIATRIC TRACHEOSTOSTOMY TUBE 60PFS35 JOH SMITHS MEDICAL ASD INC., NI

    Patients

    Seq Age Sex Outcome Treatment
    1 11 MO