BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PERFECT FIT CUFFLESS PEDIATRIC TRACH TUBE

    MDR report key: 2844346 · Received November 8, 2012

    Report

    Report Number
    3004590970-2012-00005
    Event Type
    Malfunction
    Date Received
    November 8, 2012
    Date of Event
    October 7, 2012
    Report Date
    November 7, 2012
    Manufacturer
    ARCADIA MEDICAL
    Product Code
    BTO
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS NOT RETURNED. HOWEVER, REPORT DESCRIPTION ALLOWED FOR DEVICE CODE CONCLUSION BELOW. (B)(4). INSTRUCTIONS FOR USE STATE: DO NOT USE ANY METAL OR PLASTIC HOOKS OR OBJECTS WITH SHARP EDGES (INCLUDING VELCRO NECK TIES, WHICH HAVE SHARP EDGES) SCISSORS, OR HEMOSTATS, IN OR NEAR THE REINFORCED EYELETS OF THE NECK FLANGE AS THIS MAY TEAR THE SOFT SILICONE MATERIAL RESULTING IN SPLITTING OF THE EYELETS. A TUBE WITH TORN NECK FLANGE EYELETS MAY BECOME COMPLETELY DISLODGED RESULTING IN RESPIRATORY FAILURE AND/OR DEATH. USE THE TWILL TAPE PROVIDED WITH THE PRODUCT TO SECURE THE NECK FLANGE TO THE PT IN A MANNER THAT PREVENTS THE PT FROM EASILY REMOVING OR UNTYING IT. DO NOT TIE A KNOT AROUND THE SILICONE EYELETS BECAUSE REMOVAL OF SUCH KNOT MIGHT BE DIFFICULT WITHOUT THE USE OF SCISSORS OR A SHARP OBJECT. THE TWILL TAPE SHOULD BE ABLE TO SLIDE FREELY IN AND OUT OF THE EYELET. DO NOT USE A TUBE THAT IS TORN OR DAMAGED IN ANY WAY.

    Description of Event or Problem · 1

    ON (B)(6) 2012, THE MFR RECEIVED A MEDWATCH REPORT FROM FDA DESCRIBING A "THE FLANGE WHERE THE TRACH TIES ARE ANCHORED ON THE RIGHT SIDE BROKE." THE MFR CONFIRMED THAT THE BREAK WAS AT THE NECK FLANGE EYELETS. NO PHOTOS OR ADDITIONAL DATA WERE PROVIDED. THE SITE CONFIRMED USE OF TWO-PIECE VELCRO NECK TIES WITH THE TUBES, NOT THE TWILL TAPE PROVIDED WITH THE PRODUCT. NO PT INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PERFECT FIT CUFFLESS PEDIATRIC TRACH TUBE TRACHEOSTOMY TUBE BTO ARCADIA MEDICAL 357-040 01112184

    Patients

    Seq Age Sex Outcome Treatment
    1 Other