BEUDAMED
    FDA Adverse Event Other Summary report: N

    TRACH CARE CLOSED SUCTION SYSTEM 6F

    MDR report key: 1445195 · Received August 19, 2009

    Report

    Report Number
    8030647-2009-00011
    Event Type
    Other
    Date Received
    August 19, 2009
    Date of Event
    February 27, 2009
    Report Date
    May 14, 2009
    Manufacturer
    AVENT S. DE R.L. DE C.V.
    Product Code
    BSY
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INCIDENT SAMPLE HAS NOT BEEN PROVIDED FOR EVALUATION. THE DEVICE HISTORY RECORD WAS REVIEWED FINDING NO ANOMALIES. HOWEVER, UPON REVIEW OF THE PRODUCT CODE AND INCIDENT HISTORY, THIS APPEARS TO BE RELATED TO USER-ERROR FOR CUT CATHETER. THE DIRECTIONS FOR USE CONTAINS A WARNING LABEL THAT STATES, "FULLY WITHDRAW TRACH CARE* CATHETER BEFORE CUTTING ENDOTRACHEAL TUBE, OTHERWISE THE CATHETER MAY ALSO BE CUT". 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 THAT "A 3.5-4 INCH PIECE OF CATHETER WAS FOUND LODGED IN THE BRONCHUS OF A NEONATE." THE PIECE WAS REMOVED FROM THE INFANT. NO INJURIES TO THE INFANT WERE REPORTED. NO ADDITIONAL INFORMATION HAS BEEN RECEIVED AT THIS TIME. 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 6F TRACH CARE BSY AVENT S. DE R.L. DE C.V. M9082T703

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention