BEUDAMED
    FDA Adverse Event Other Summary report: N

    TRACH CARE CLOSED SUCTION SYSTEM FOR ADULTS

    MDR report key: 1541905 · Received November 10, 2009

    Report

    Report Number
    8030647-2009-00015
    Event Type
    Other
    Date Received
    November 10, 2009
    Date of Event
    August 17, 2009
    Report Date
    October 12, 2009
    Manufacturer
    AVENT S. DE R.L. DE C.V.
    Product Code
    BSY
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE USER HOSPITAL HAS REPORTED THIS INCIDENT AS "USER ERROR." A SAMPLE WILL NOT BE RETURNED FOR EVALUATION, AND THE LOT # OF THE DEVICE WAS NOT PROVIDED; THEREFORE, THE DEVICE HISTORY RECORD COULD NOT BE REVIEWED. THE DIRECTIONS FOR USE CONTAINS A WARNING THAT STATES "CAP ON TRACH CARE* T-PIECE PREVENTS CONTINUOUS FLOW THERAPY. REMOVE CAP BEFORE STARTING CONTINUOUS FLOW THERAPY. FAILURE TO REMOVE CAP PRIOR TO CONTINUOUS FLOW THERAPY MAY RESULT IN SERIOUS INJURY OR DEATH." WE WILL CONTINUE TO CLOSELY MONITOR THE FIELD PERFORMANCE OF THIS PRODUCT TO IDENTIFY EMERGING TRENDS AND IF APPLICABLE, ADDITIONAL INVESTIGATIONS AND CORRECTIVE ACTIONS WILL BE TAKEN.

    Description of Event or Problem · 1

    KIMBERLY CLARK RECEIVED A COMPLAINT INDICATING "TRACH COLLAR CHANGED TO IN-LINE SUCTION. EXHALATION CAP WAS LEFT ON, NOT ALLOWING FOR EXHALATION." THE PATIENT WAS BRADYCARDIC, UNRESPONSIVE, AND CYANOTIC. THE USER HOSPITAL REPORTED THIS INCIDENT AS A "USER ERROR" AS THE THERAPIST FAILED TO REMOVE THE CAP. THE PATIENT IMMEDIATELY RESPONDED WELL TO BAGGING WITH IN-LINE SUCTION REMOVED. NO OTHER PROBLEMS WERE NOTED. KIMBERLY-CLARK HAS NO INDEPENDENT KNOWLEDGE OF THE EVENT REPORTED BUT IS RELAYING THE INFORMATION THAT WAS PROVIDED BY THE USER FACILITY WHERE THE INCIDENT OCCURRED. THIS PRODUCT INCIDENT IS DOCUMENTED IN THE KIMBERLY-CLARK COMPLAINT DATABASE AND IDENTIFIED AS PIR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TRACH CARE CLOSED SUCTION SYSTEM FOR ADULTS CLOSED SUCTION SYSTEM 14F - TPIECE BSY AVENT S. DE R.L. DE C.V.

    Patients

    Seq Age Sex Outcome Treatment
    1 30 YR Required Intervention