BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PORTEX® BIVONA CUSTOMIZATION SERVICES

    MDR report key: 7082753 · Received December 5, 2017

    Report

    Report Number
    3012307300-2017-02513
    Event Type
    Injury
    Date Received
    December 5, 2017
    Date of Event
    November 25, 2017
    Report Date
    January 8, 2018
    Manufacturer
    SMITHS MEDICAL ASD, INC.
    Product Code
    JOH
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DE, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    SMITHS MEDICAL RECEIVED ONE PORTEX BIVONA FLEXTEND¿ TRACHEOSTOMY (TRACH) FOR ANALYSIS. A PARTIALLY TORN EYELET AND THE EYELETS WERE CUT/TORN WITH MINIMAL INTACT SILICONE REMAINING WAS NOTED TO THE DEVICE UPON VISUAL EXAMINATION. THE EYELETS WERE PULL TESTED TO BREAK USING AN INSTRON MACHINE WHEN TESTING WAS PERFORMED. INSTRUCTIONS FOR USE WAS REVIEWED WITH FOLLOWING WARNING STATEMENT: "GUARD AGAINST PRODUCT DAMAGE BY AVOIDING CONTACT WITH SHARP EDGES. SOME TRACHEOSTOMY TUBE HOLDERS CONTAIN VELCRO OR METAL CLIPS WHICH MAY HAVE SHARP EDGES. THESE SHARP EDGES CAN COME INTO CONTACT WITH THE EYELETS AND COMPROMISE THE PRODUCT INTEGRITY. A DAMAGED EYELET CAN RESULT IN DECANNULATION OF THE TRACHEOSTOMY TUBE. SMITHS MEDICAL RECOMMENDS USING THE TWILL TAPE HOLDER SUPPLIED WITH THE PRODUCT." BASED ON THE EVIDENCE, THE COMPLAINT WAS OBSERVED BUT THE ROOT CAUSE IS UNKNOWN.

    Description of Event or Problem · 1

    INFORMATION WAS RECEIVED INDICATING THAT, WHILE IN USE WITH A PATIENT, THE FLANGE OF THIS TRACHEOSTOMY TUBE TORE. AN EMERGENCY TRACHEOSTOMY TUBE CHANGE TOOK PLACE. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    861569 PORTEX® BIVONA CUSTOMIZATION SERVICES TUBE TRACHEOSTOMY AND TUBE CUFF JOH SMITHS MEDICAL ASD, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 9 YR Required Intervention