BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BIVONA® UNCUFFED PEDIATRIC STRAIGHT NECK FLANGE TRACHEOSTOMY TUBES

    MDR report key: 5885781 · Received August 18, 2016

    Report

    Report Number
    2183502-2016-01757
    Event Type
    Malfunction
    Date Received
    August 18, 2016
    Report Date
    July 21, 2016
    Manufacturer
    SMITHS MEDICAL ASD INC.
    Product Code
    JOH
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    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. SMITHS MEDICAL WILL FILE A FOLLOW-UP REPORT DETAILING THE RESULTS OF THE EVALUATION ONCE IT IS COMPLETED. THE 510K NUMBERS K912469 & K083641.

    Additional Manufacturer Narrative · 1

    ONE 5.0MM STANDARD CUFFLESS TRACHEOSTOMY TUBE WAS RETURNED FOR INVESTIGATION. VISUAL INSPECTION, PERFORMED USING THE UNAIDED EYE, REVEALED THAT A SPLIT HAD DEVELOPED IN ONE OF THE FLANGE EYELETS. NO ADDITIONAL PRODUCT ISSUES WERE OBSERVED. FURTHER INVESTIGATION FOUND THAT THE SPLIT BEGAN AS A SMOOTH SURFACE AND LEAD TO A JAGGED SURFACE. THE OBSERVATION OF SPLIT SURFACE WAS FOUND TO BE CONSISTENT WITH THE SPLIT STARTING AS A CUT/NICK ON THE INNER WALL OF THE EYELET OPENING AND PROPAGATING INTO A TEAR. A PULL TEST WAS CONDUCTED ON THE OPPOSING EYELET TO DETERMINE THE EYELET STRENGTH; THE RESULT OF THE PULL TEST CONFIRMED THAT THE PRODUCT MET THE REQUIRED SPECIFICATIONS. INVESTIGATION WAS UNABLE TO DETERMINE THE ROOT CAUSE OF THE EYELET SPLIT. (B)(4).

    Description of Event or Problem · 1

    THIS EVENT OCCURRED IN (B)(6). IT WAS REPORTED FROM THE USER FACILITY THAT THE FLANGE EYELET WAS TORN DURING USE ON THE BIVONA UNCUFFED PEDIATRIC STRAIGHT NECK FLANGE TRACHEOSTOMY TUBE. THERE WAS NO ADVERSE EVENT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    538863 BIVONA® UNCUFFED PEDIATRIC STRAIGHT NECK FLANGE TRACHEOSTOMY TUBES TUBE TRACHEOSTOMY AND TUBE CUFF JOH SMITHS MEDICAL ASD INC.

    Patients

    Seq Age Sex Outcome Treatment
    1