BEUDAMED
    FDA Adverse Event Other Summary report: N

    TRACH CARE NEONATAL "Y" 6F

    MDR report key: 1424218 · Received March 27, 2009

    Report

    Report Number
    8030647-2009-00006
    Event Type
    Other
    Date Received
    March 27, 2009
    Date of Event
    September 8, 2008
    Report Date
    March 25, 2009
    Manufacturer
    AVENT S. DE R.L. DE C.V.
    Product Code
    BSY
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE CATHETER TIP WAS RECEIVED AND EVALUATED. THE TIP SHOWED A DIAGONAL CUT. BASED UPON THE EVAL OF THE INCIDENT SAMPLE AND INVESTIGATIONS FOR SIMILAR COMPLAINTS FOR THE FAILURE MODE IDENTIFIED, THIS COMPLAINT IS RELATED TO A USER ERROR "CUT CATHETER". IT SHOULD BE NOTED THAT IN THE PRODUCT'S DIRECTIONS FOR USE, THE WARNING LABEL CLEARLY STATES "FULLY WITHDRAW TRACH CARE CATHETER BEFORE CUTTING ENDOTRACHEAL TUBE, OTHERWISE THE CATHETER MAY ALSO BE CUT." NO ADDITIONAL INFORMATION HAS BEEN RECEIVED. WE WILL CONTINUE TO CLOSELY MONITOR THE FIELD PERFORMANCE OF THIS PRODUCT TO IDENTIFY EMERGING TRENDS AND IF APPLICABLE, ADDITIONAL INVESTIGATIONS WILL BE INITIATED AND CORRECTIVE ACTION TAKEN IF INDICATED. INFO FROM THIS INCIDENT WILL BE INCLUDED IN OUR PRODUCT COMPLAINT & MDR TREND REPORTING SYSTEMS. ONGOING ANALYSIS OF TREND INFO IS USED TO IDENTIFY THE NEED FOR ADDITIONAL INVESTIGATIONS.

    Description of Event or Problem · 1

    IT HAS BEEN REPORTED TO KIMBERLY-CLARK THAT WHILE THE STAFF WAS ATTEMPTING TO BOTTLE FEED AN INFANT, THE INFANT VOMITED A 2" PLASTIC TUBE WITH A BLACK TIP. THIS EVENT TOOK PLACE IN (B)(6) 2008 AND WAS NOT REPORTED TO THE KIMBERLY CLARK SALES REP UNTIL (B)(6), 2008. THERE WAS NO REPORT OF ANY SERIOUS INJURIES TO THE INFANT. THE INFANT IS REPORTED TO BE IN STABLE CONDITION. KIMBERLY-CLARK HAS NO INDEPENDENT KNOWLEDGE OF THE EVENT REPORTED BUT IS RELAYING THE INFO 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 (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TRACH CARE NEONATAL "Y" 6F TRACH CARE BSY AVENT S. DE R.L. DE C.V. 426867

    Patients

    Seq Age Sex Outcome Treatment
    1