BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MICROCUFF ENDOTRACHEAL TUBE W/STYLET, 7.5MM

    MDR report key: 4203086 · Received October 23, 2014

    Report

    Report Number
    9611710-2014-00317
    Event Type
    Injury
    Date Received
    October 23, 2014
    Date of Event
    September 20, 2014
    Report Date
    September 26, 2014
    Manufacturer
    UNOMEDICAL SDN BHD
    Product Code
    BTR
    PMA / PMN Number
    K951696
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TH
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    ON (B)(6) 2014, THE PATIENT WAS ADMITTED TO THE HOSPITAL WITH C3, C4 SPINAL INJURIES AFTER A DIVING ACCIDENT. HE WAS REPORTED AS AGITATED WITH "AGGRESSIVE HEAD MOTIONS". ON (B)(6) 2014, ALTHOUGH A COMPETITOR'S ORAL ENDOTRACHEAL TUBE SECUREMENT SYSTEM WAS IN PLACE, THE PATIENT WAS ABLE TO BITE THE ENDOTRACHEAL TUBE INTO TWO (2) PIECES. MAGILL FORCEPS WERE USED TO RETRIEVE THE OTHER HALF FROM THE AIRWAY. THE PATIENT CODED, AND RESUSCITATED, AND REINTUBATED. NO INJURY WAS REPORTED AS A RESULT OF THE INCIDENT. BASED ON THE AVAILABLE INFORMATION, THIS EVENT IS DEEMED TO BE A SERIOUS INJURY. NO FURTHER INFORMATION WAS AVAILABLE AT THE TIME OF THE REPORT, HOWEVER AN INVESTIGATION IS IN PROGRESS. A RETURN SAMPLE FOR EVALUATION IS NOT EXPECTED AND THE LOT NUMBER WAS NOT PROVIDED. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED. REPORTED TO THE FDA ON OCTOBER 23, 2014.

    Description of Event or Problem · 1

    IT IS REPORTED THAT A VENTILATED PATIENT WAS ABLE TO BITE THROUGH HIS ENDOTRACHEAL TUBE ON DAY SIX (6) OF INTUBATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    675397 MICROCUFF ENDOTRACHEAL TUBE W/STYLET, 7.5MM TUBE, TRACHEAL (W/WO CONNECTOR) BTR UNOMEDICAL SDN BHD 35215 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 31 YR Hospitalization| L| R