BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SMITHS MEDICAL BIVONA TUBES NEO/PED HYPERFLEX

    MDR report key: 9371228 · Received November 25, 2019

    Report

    Report Number
    3012307300-2019-06798
    Event Type
    Malfunction
    Date Received
    November 25, 2019
    Date of Event
    November 18, 2019
    Report Date
    May 7, 2020
    Manufacturer
    SMITHS MEDICAL ASD, INC.
    Product Code
    JOH
    UDI-DI
    15021312013702
    PMA / PMN Number
    K081440
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    501

    Narratives

    Additional Manufacturer Narrative · 0

    RETURNED DEVICE WAS RECEIVED IN GOOD PHYSICAL CONDITION. DURING THE EVALUATION OF THE DEVICE, IT WAS FOUND THAT THE DEVICE COULD MOVE FREELY AND THE LOCKING MECHANISM WORKED JUST FINE. THERE IS SPECULATION THAT THE DEFECT WAS CORRECTLY COMMUNICATED OR THE CORRECT DEVICE WAS RETURNED. ADDITIONALLY SINCE THE NECK FLANGE ROTATES AROUND THE SHAFT, REPOSITIONING THE NECK FLANGE SO THE FLANGES ARE NOT UPSIDE DOWN WOULD HAVE CORRECTED THE CONCERN AND TYPICALLY NOT WARRANTED A COMPLAINT. THE DEVICE HISTORY RECORD WAS REVIEWED AND SHOWED THAT THIS DEVICE MET ALL MANUFACTURING SPECIFICATION FOR PRODUCT RELEASED FOR DISTRIBUTION. NO ISSUES WERE IDENTIFIED THAT WOULD HAVE IMPACTED THIS EVENT.

    Additional Manufacturer Narrative · 0

    DEVICE EVALUATION IN PROGRESS.

    Description of Event or Problem · 0

    INFORMATION WAS RECEIVED THAT A SMITHS MEDICAL BIVONA HYPERFLEX TRACHEOSTOMY TUBE HAD A NECK PLATE ON UPSIDE DOWN. AS A RESULT, THE PATIENT WAS NOT PROPERLY VENTILATED, AND A NEW TRACHEOSTOMY WAS INSERTED. IT WAS FURTHER REPORTED THAT THE USER NOTICED UNSPECIFIED PROBLEMS WITH TWO ADDITIONAL BIVONA HYPERFLEX TRACHEOSTOMY TUBES. THESE UNSPECIFIED PRODUCT ISSUES WERE IDENTIFIED PRIOR TO PATIENT USE.

    Description of Event or Problem · 1

    INFORMATION WAS RECEIVED THAT A SMITHS MEDICAL BIVONA HYPERFLEX TRACHEOSTOMY TUBE HAD A NECK PLATE ON UPSIDE DOWN. AS A RESULT, THE PATIENT WAS NOT PROPERLY VENTILATED, AND A NEW TRACHEOSTOMY WAS INSERTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1164321 SMITHS MEDICAL BIVONA TUBES NEO/PED HYPERFLEX TUBE TRACHEOSTOMY AND TUBE CUFF JOH SMITHS MEDICAL ASD, INC. 60HA35 38001467 15021312013702

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention