BEUDAMED
    FDA Adverse Event Other Summary report: N

    TRACH CARE CLOSED SUCTION SYSTEM FOR ADULTS

    MDR report key: 1541897 · Received November 4, 2009

    Report

    Report Number
    8030647-2009-00014
    Event Type
    Other
    Date Received
    November 4, 2009
    Date of Event
    June 1, 2009
    Report Date
    October 5, 2009
    Manufacturer
    AVENT S. DE R.L. DE C.V.
    Product Code
    BSY
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INCIDENT SAMPLE AND LOT NUMBER HAVE NOT BEEN PROVIDED FOR EVALUATION; THEREFORE, THE DEVICE HISTORY RECORD COULD NOT BE REVIEWED. REVIEW OF THE INCIDENT SUGGESTS THAT THIS EVENT INVOLVES A USER-ERROR, WHEREBY THE SUCTION CATHETER OF THE TRACH CARE DEVICE WAS INADVERTENTLY CUT WHILE THE USER WAS TRIMMING THE PATIENT'S ENDOTRACHEAL TUBE (NOT PROVIDED WITH UNIT) WITHOUT FIRST FULLY WITHDRAWING THE TRACH CARE SUCTION CATHETER. THIS LIKELY RESULTED IN THE SUCTION CATHETER MISTAKENLY BEING CUT WHILE CUTTING THE ENDOTRACHEAL TUBE. THE DIRECTIONS FOR USE SUPPLIED WITH THE DEVICE CONTAINS A WARNING LABEL THAT STATES "FULLY WITHDRAW TRACH CARE* CATHETER BEFORE CUTTING ENDOTRACHEAL TUBE, OTHERWISE THE CATHETER MAY ALSO BE CUT." NO ADDITIONAL INFORMATION HAS BEEN RECEIVED. THIS COMPLAINT INVESTIGATION HAS BEEN COMPLETED AND THE COMPLAINT IS CLOSED. 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. * A CUSTOMER NOTIFICATION WAS RECENTLY SENT TO UNITED STATES CUSTOMERS OF THE TRACH CARE CLOSED SUCTION DEVICE NOTIFYING THE USERS OF THE POTENTIAL HAZARD DUE TO USER ERROR INVOLVING THE INADVERTENT CUTTING OF CATHETERS WHILE TRIMMING ET TUBES AND REEMPHASIZING THE EXISTING WARNING STATEMENT RELATIVE TO THIS ISSUE.

    Description of Event or Problem · 1

    KIMBERLY CLARK RECEIVED AN FDA MEDWATCH REPORT (B)(4) INDICATING THAT "PATIENT WAS TRACHED WHILE IN OUR ICU, SHE WAS THEN TRANSFERRED FROM OUR HOSPITAL TO A SPECIALTY UNIT IN 2009. PATIENT BEGAN DEVELOPING RESPIRATORY PROBLEMS THE FOLLOWING MONTH. PATIENT HAD BRONCHOSCOPY WHICH SHOWED A PORTION OF SUCTION TUBING IN HER LUNG." BRONCHOSCOPY REVEALED A 10CM LENGTH PORTION OF SUCTION TUBING IN HER LUNG. IT WAS REPORTED THAT TUBING PIECE WAS REMOVED WITHOUT ANY INJURY TO THE PATIENT. THE TRACH CARE CATHETER SUCTION TUBING IS SUPPLIED AS A SINGLE 54 CM LENGTH TUBE. 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, DOUBLE SWIVEL ELBOWS BSY AVENT S. DE R.L. DE C.V.

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention