BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADULT 8.0MM ET TUBE WITH SUBGLOTTIC SUCTIONING

    MDR report key: 4200721 · Received October 24, 2014

    Report

    Report Number
    9611594-2014-00143
    Event Type
    Malfunction
    Date Received
    October 24, 2014
    Report Date
    September 27, 2014
    Manufacturer
    KIMBERLY-CLARK HEALTH CARE
    Product Code
    BTR
    PMA / PMN Number
    PK131254
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE ACTUAL COMPLAINT PRODUCT WAS NOT RETURNED FOR EVALUATION. A REVIEW OF THE DEVICE HISTORY RECORD IS IN-PROGRESS. UPON COMPLETION OF THE INVESTIGATION; A FOLLOW-UP REPORT WILL BE FILED. (B)(4).

    Description of Event or Problem · 1

    KIMBERLY-CLARK RECEIVED A REPORT FROM (B)(6) STATING DURING THE PATIENT'S MORNING SUCTION CONTROL PROCESS THE PATIENT STARTED TO COUGH HEAVILY. THE CLINICIANS CHECKED FOR POSSIBLE CAUSES AND FOUND OUT THAT THE MICROCUFF WAS EMPTY AND COULD NOT BE REINFLATED. THE PILOT CUFF INFLATION LINE DETACHED. THE PATIENT WAS EXTUBATED AN REINTUBATED. THE CLINICIANS WERE UNABLE RULE OUT THE POSSIBILITY THAT THE PATIENT, WHO SUFFERS HYPOXIC BRAIN INJURY WITH INTERMITTENT MYOCLONIA, CHEWED ON THE TUBE. NO ADDITIONAL INFORMATION WAS PROVIDED IN REGARDS TO THE PATIENT'S STATUS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    680177 ADULT 8.0MM ET TUBE WITH SUBGLOTTIC SUCTIONING ENDOTRACHEAL TUBE BTR KIMBERLY-CLARK HEALTH CARE 13222 AA3249V01

    Patients

    Seq Age Sex Outcome Treatment
    1 Life Threatening