BEUDAMED
    FDA Adverse Event Other Summary report: N

    TRACH CARE CLOSED SUCTION FOR PEDIATRICS

    MDR report key: 1570522 · Received December 22, 2009

    Report

    Report Number
    8030647-2009-00016
    Event Type
    Other
    Date Received
    December 22, 2009
    Report Date
    December 3, 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
    MN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE INCIDENT SAMPLE AND LOT NUMBER HAVE NOT BEEN PROVIDED FOR EVAL; 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 PT'S ENDOTRACHEAL TUBE (NOT PROVIDED WITH THE 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 INFO 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 US CUSTOMERS FOR 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. THIS NOTIFICATION REEMPHASIZED THE EXISTING WARNING STATEMENT RELATIVE TO THE ISSUE.

    Description of Event or Problem · 1

    KIMBERLY CLARK RECEIVED A COMPLAINT INDICATING THAT "A PART OF THE SUCTION CATHETER WAS SEEN IN THE CHEST X-RAY OF A PRETERM BABY AND WAS REMOVED BY A BRONCHOSCOPE." IT SHOULD BE NOTED THAT THE FOREIGN BODY WAS NOT DETECTED FROM (B)(6) 2009 UNTIL THE CHEST X-RAY DONE ON (B)(6) 2009. THE PHYSICIAN REPORTED THE PT'S PROGNOSIS AS "GOOD." 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 CLOSED SUCTION FOR PEDIATRICS CLOSED SUCTION SYSTEM FOR PEDIATRICS BSY AVENT S. DE R.L. DE C.V.

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention