BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BIVONA FLEXTEND SILICONE TRACHEOSTOMY TUBE

    MDR report key: 2093798 · Received May 12, 2011

    Report

    Report Number
    MW5020586
    Event Type
    Injury
    Date Received
    May 12, 2011
    Date of Event
    August 7, 2010
    Report Date
    May 12, 2011
    Manufacturer
    SMITHS MEDICAL ASD, INC.
    Product Code
    JOH
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    FL, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    MY (B)(6) SON HAS HAD A TRACHEOSTOMY SINCE HE WAS 5 MONTHS OLD. HE USED A BIVONA TUBE BY SMITHS MEDICAL, AND ABOUT 4 YEARS AGO, CHANGED TO THE FLEXTEND. SOME TIME AFTER (B)(6) 2009, SMITHS MEDICAL CHANGED THE DESIGN. THERE WERE SEVERAL CHANGES (SOME OF WHICH I MAY NOT KNOW), BUT HE DOES NOT TOLERATE THE NEW DESIGN. I HAVE CONTACTED SMITHS ON NUMEROUS OCCASIONS AND THEY SAY, THEIR CHANGES WERE BASED ON INFO FROM A NUMBER OF CHILDREN'S HOSPITALS. HOWEVER, ONE CHANGE, WHERE THE METAL GOES ALL THE WAY DOWN THE TRACH TUBE HAS CAUSED MY SON IRRITATION AROUND THE TRACH, INCREASED SECRETIONS, ETC. I TRIED IT ON MORE THAN ONE OCCASION AND HAD TO SWITCH BACK TO THE OLD TYPE OF TUBE. OUR (B)(6) NURSES ALSO NOTED THE PROBLEMS WITH THE NEW DESIGN BEFORE IT CAUSED SUCH A PROBLEM THAT WE HAD TO HOSPITALIZE HIM. MY PROBLEM NOW IS THAT, I AM RUNNING OUT OF THE OLD TYPE OF TUBES AND I'M CAUGHT IN THE MIDDLE WITH MY INSURANCE COMPANY AND SMITHS MEDICAL. OF COURSE, SMITHS SAYS TO GET THE OLD TYPE OF TUBE, IT IS NOW A "SPECIAL ORDER" -THEREFORE MORE EXPENSIVE-. ANY IDEAS? IF NOTHING ELSE, I DO WANT TO HAVE IT DOCUMENTED THAT MY SON DID NOT TOLERATE THE NEW TYPE OF TUBE. IRRITATION WAS NOTED WITHIN 12 HOURS, WE REMOVED IT BOTH TIMES WITHIN 48-72 HOURS. DATES OF USE: (B)(6) 2010 AND (B)(6) 2010 ALSO. DIAGNOSIS OR REASON FOR USE: CEREBRAL PALSY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BIVONA FLEXTEND SILICONE TRACHEOSTOMY TUBE TRACHEOSTOMY TUBE JOH SMITHS MEDICAL ASD, INC. 60PFS55 1704701

    Patients

    Seq Age Sex Outcome Treatment
    1 13 YR Other OLD TYPE OF TRACH - PREFERRED, NO PROBLEMS - AND| THE CHILD SEES THE DOCTOR MONTHLY. I TOOK BOTH THE| THE NEW TRACH. HE HAD NOT SEEN THE NEW ONE YET,| PART INSERTED IN THE NECK, THE OLD TYPE DID NOT GO| ALL THE WAY DOWN INTO THE NECK.| BUT NTOED THAT THE METAL WENT ALL THE WAY DOWN THE