BEUDAMED
    FDA Adverse Event Other Summary report: N

    ADULT TRACH CARE 72 HOURS

    MDR report key: 1587892 · Received December 29, 2009

    Report

    Report Number
    8030647-2009-00018
    Event Type
    Other
    Date Received
    December 29, 2009
    Report Date
    December 21, 2009
    Manufacturer
    AVENT S. DE RL DE CV
    Product Code
    BSY
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    NURSE

    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. THE USER FACILITY REPORTED THIS ISSUE AS 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 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 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. 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 OF THE TRACH CARE CLOSED SUCTION DEVICE WHICH NOTIFIED 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 A COMPLAINT REPORTING THAT AFTER EXTUBATION, A PT WAS GAGGING AND COUGHED UP A 2CM BY 2MM IN DIAMETER SEGMENT OF A CATHETER. IT IS NOT KNOWN HOW LONG THE CATHETER HAD BEEN IN USE. THE PT WAS REPORTED TO BE DOING WELL AND REMAINS IN THE HOSPITAL FOR UNRELATED REASONS. 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. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ADULT TRACH CARE 72 HOURS CLOSED SUCTION SYSTEM FOR ADULTS BSY AVENT S. DE RL DE CV

    Patients

    Seq Age Sex Outcome Treatment
    1