BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BIVONA

    MDR report key: 10477808 · Received September 1, 2020

    Report

    Report Number
    3012307300-2020-08901
    Event Type
    Malfunction
    Date Received
    September 1, 2020
    Date of Event
    August 1, 2020
    Report Date
    January 6, 2021
    Manufacturer
    SMITHS MEDICAL ASD, INC.
    Product Code
    JOH
    UDI-DI
    15021312516777
    PMA / PMN Number
    K94417J8
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 0

    OTHER, OTHER TEXT: INVESTIGATION COMPLETED ON A SMITHS MEDICAL TRACHEOSTOMY/SILICONE - BIVONA TUBES NEO/PED FLEXTEND PLUS . FOUR PICTURES WERE RECEIVED REVEALING: SAMPLE 1: SHAFT WAS SEPARATED FROM THE CONNECTOR AND THE WIRE WAS EXPOSED; ALSO, WE OBSERVED THE WHOLE ADHESIVE WAS ATTACHED TO THE CONNECTOR. PICTURE 2: SPLIT IN THE TUBE. SAMPLE 3: LABELLING FROM P/N 60PFSS35, L/N 387418. 4: BROKEN NECKSTRAP. THE COMPLAINT WAS VISUALLY INSPECTED AND VALIDATED . THE CAUSE IS BELIEVED TO BE RELATED TO VELCRO NECK STRAPS, AS THIS DEVICES HAVE SHARP EDGES AND CAN CAUSE HARM TO THE TRACH. IT IS RECOMMENDED BY THE MANUFACTURE TO USE TWILL CLOTH FOR NECK STRAPS. ALL MITIGATIONS ON PLACED WERE VERIFIED AND IT WAS CONFIRMED HAS BEEN EXECUTING ACCORDING, THEREFORE NO CORRECTIVE ACTIONS COULD BE IMPLEMENTED, IT WILL BE CONTINUE MONITORING THIS FAILURE CONDITION IN THIS PRODUCT FOR THRESHOLD OR ESCALATION.

    Description of Event or Problem · 1

    INFORMATION RECEIVED A SMITHS MEDICAL TRACHEOSTOMY/SILICONE - BIVONA TUBES NEO/PED FLEXTEND PLUS MALFUNCTIONED CAUSING A TRACHEOSTOMY CHANGE OUT BY MOM ON (B)(6) 2020. ONE TUBE HAD A CRACK WHERE THE FLANGE MEETS THE HUB AND ALSO HAS WIRE EXPOSED FROM THE CANNULA BEING PULLED AWAY FROM THE HUB. PHOTOS ARE ATTACHED. NO PATIENT ADVERSE EVENTS REPORTED, HOWEVER TRACHEOSTOMY CHANGE OUT MAY IMPEDED AIRWAY MANAGEMENT AND DEVICE IS LIFE SUSTAINING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    943165 BIVONA TRACHEOSTOMY JOH SMITHS MEDICAL ASD, INC. 60PFSS35 3874318 15021312516777

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention