BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BIVONA

    MDR report key: 11808881 · Received May 11, 2021

    Report

    Report Number
    3012307300-2021-04208
    Event Type
    Injury
    Date Received
    May 11, 2021
    Date of Event
    April 10, 2021
    Report Date
    January 20, 2022
    Manufacturer
    SMITHS MEDICAL ASD, INC.
    Product Code
    JOH
    UDI-DI
    15021312005776
    PMA / PMN Number
    K912469
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION COMPLETED ON A SMITHS MEDICAL TRACHEOSTOMY/SILICONE - BIVONA TUBES NEO/PED. FOUR PICTURES RECEIVED WITH A CUT IN THE CORNER OF NECK STRAP, WHICH CONFIRMED COMPLAINT. QUALITY TAKES A REPRESENTATIVE SAMPLE AND PERFORMS A VISUAL INSPECTION FOR SPLITS/CUTS, EXPOSED WIRE ACCORDING TO QP BIVONA TT-FG-TJ.ROOT CAUSE BASED ON THE TESTS PERFORMED THE FAILURE MODE COULD NOT BE REPRODUCED DURING MOLDING PROCESS. THE MOST PROBABLE ROOT CAUSE IS THAT DAMAGED OCCURRED AFTER THE PRODUCT LEFT SMITHS MEDICAL FACILITIES. ON SECTION 4.10 STATES: ?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. WE RECOMMEND USING THE TWILL TAPE HOLDER SUPPLIED WITH THE PRODUCT.? BASED ON IFU INSTRUCTIONS, NECKSTRAPS COULD BE DAMAGED BY CONTACT WITH SHARP EDGES FROM TRACHEOSTOMY HOLDERS. THEREFORE, IT IS RECOMMENDABLE USE THE TWILL TAPE HOLDER SUPPLIED WITH THE PRODUCT.

    Additional Manufacturer Narrative · 0

    FILE PREVIOUSLY REPORTED AS MALFUNCTION IN ERROR. TYPE OF EVENT UPDATED TO SERIOUS INJURY DUE TO REQUIREMENT OF TRACHEOSTOMY CHANGE OUT.

    Description of Event or Problem · 0

    DEVICE EVALUATION COMPLETED AND SUMMARY.

    Additional Manufacturer Narrative · 1

    ONLY THE MONTH (B)(6) AND YEAR (2021) OF THE EVENT DATE ARE KNOWN. CUSTOMER FACILITY PHONE NUMBER: (B)(6). DEVICE EVALUATION IN PROGRESS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WHILE REPLACING THE NECK TAPE (AS PART OF A DAILY ROUTINE), THE OPERATOR NOTICED A CRACK IN THE LEFT NECK FLANGE. NO PATIENT INJURY OR COMPLICATIONS WERE REPORTED IN RELATION TO THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    702104 BIVONA TUBE TRACHEOSTOMY AND TUBE CUFF JOH SMITHS MEDICAL ASD, INC. 60P050 15021312005776
    702114 BIVONA TUBE TRACHEOSTOMY AND TUBE CUFF JOH SMITHS MEDICAL ASD, INC. 60P050 15021312005776

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown