BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PORTEX BIVONA FLEXTEND TRACHEOSTOMY TUBES

    MDR report key: 10537384 · Received September 15, 2020

    Report

    Report Number
    3012307300-2020-09337
    Event Type
    Injury
    Date Received
    September 15, 2020
    Report Date
    October 30, 2020
    Manufacturer
    SMITHS MEDICAL ASD, INC.
    Product Code
    JOH
    UDI-DI
    15021312516791
    PMA / PMN Number
    K944178
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    PHOTOS OF THE DEVICE WERE RECEIVED FOR EVALUATION. DURING THE EVALUATION OF THE DEVICE THE CUSTOMER REPORTED CONDITION WAS CONFIRMED PROBLEM SOURCE IS UNKNOWN. DURING THE DHR REVIEW, WE CONFIRMED THAT P/N 60PFSS45 L/N 3991195 WAS ASSEMBLED USING A STRAIGHT FLANGE P/N NKS-CLL-045-4 L/N 4018618 WHICH IS CORRECT ACCORDING TO ITS BILL OF MATERIALS AND LABELLING.

    Additional Manufacturer Narrative · 1

    OTHER, OTHER TEXT: THE AVAILABLE INFORMATION SUGGESTS THAT FOUR UNITS WERE INVOLVED. FOUR COMPLAINTS WERE CREATED TO REFLEX THE AVAILABLE INFORMATION. AT THIS TIME, IT IS UNCERTAIN AS TO WHICH V FLANGE TRACH TUBE WAS THE ONE USED ON THE PATIENT. (B)(4).

    Description of Event or Problem · 1

    INFORMATION WAS RECEIVED INDICATING THAT THE LABELING ON THE BOX TO A SMITHS MEDICAL PORTEX BIVONA FLEXTEND TRACHEOSTOMY TUBE WAS FOUND CORRECT BUT THE TRACH TUBES IN THE BOX WERE NOT. IT WAS REPORTED THAT THE BOX CONTAINED V FLANGE TRACH'S AND THE STICKER ON THE BOX READS STRAIGHT. ONE OF THE FOUR V FLANGE TRACH'S THAT WAS SENT TO THE PATIENT WAS THEN PLACED IN THE PATIENT. THE PATIENT HAD COMPLAINTS OF THE TUBE CAUSING DISTRESS WITH AN INCREASE IN SECRETIONS TOWARD THE END OF AUGUST. BECAUSE OF THE SECRETIONS, THE PATIENT WENT TO THE CLINIC WHERE THEY WERE REPORTED TO HAVE ANTIBIOTICS PRESCRIBED. THERE WERE NO FURTHER REPORTED ADVERSE EFFECTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1003155 PORTEX BIVONA FLEXTEND TRACHEOSTOMY TUBES TUBE TRACHEOSTOMY AND TUBE CUFF JOH SMITHS MEDICAL ASD, INC. 60PFSS45 3868200 15021312516791

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R