BEUDAMED
    FDA Adverse Event Injury Summary report: N

    KIMVENT CLOSED SUCTION SYSTEM FOR ADULTS

    MDR report key: 2200823 · Received August 11, 2011

    Report

    Report Number
    8030647-2011-00040
    Event Type
    Injury
    Date Received
    August 11, 2011
    Report Date
    July 12, 2011
    Manufacturer
    KIMBERLY-CLARK HEALTH CARE
    Product Code
    BSY
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THE REVIEW OF THE DEVICE HISTORY RECORD SHOWS THE PRODUCT MET MANUFACTURING SPECIFICATIONS AND WAS ACCEPTED IN QA INSPECTIONS. THE DEVICE WAS RETURNED FOR ANALYSIS. DEVICE EVALUATION SHOWED THE CATHETER TO BE EASILY ADVANCED AND RETRACTED THROUGH THE PEEP SEAL. MEASUREMENTS OF THE CATHETER AND THE PEEP SEAL WERE TAKEN, BASED ON THE MEASUREMENTS THE CATHETER SHOULD ADVANCE AND RETRACT THROUGH THE PEEP SEAL WITHOUT DIFFICULTY. THE 2201258 IS AN ENDOTRACHEAL LENGTH DEVICE AND WAS USED FOR A PATIENT WITH A TRACHEOSTOMY. THE DIRECTIONS FOR USE STATE, "DO NOT USE 54CM (21.3 INCH) CATHETERS ON TRACHEOSTOMY PATIENTS. MUCOSAL DAMAGE MAY RESULT." INFORMATION FROM THIS INCIDENT WILL BE INCLUDED IN OUR PRODUCT COMPLAINT AND MDR TREND REPORTING SYSTEMS. ONGOING ANALYSIS OF TREND INFORMATION IS USED TO IDENTIFY THE NEED FOR ADDITIONAL INVESTIGATIONS.

    Description of Event or Problem · 1

    KIMBERLY-CLARK RECEIVED A REPORT STATING, "LAY USER WAS SUCTIONING PATIENT WITH THE CLOSED SUCTION CATHETER; WHEN INSERTED INTO THE TRACH TUBE THE CATHETER ADVANCED EASILY BUT WAS USER WAS UNABLE TO WITHDRAW THE CATHETER FROM THE AIRWAY. PATIENT WAS SHOWING SIGNS OF RESPIRATORY DISTRESS. CAREGIVER WAS ABLE TO REMOVE TRACH TUBE INNER CANNULA AND REMOVE THE CLOSED SUCTION CATHETER. PATIENT IS ABLE TO BREATHE ON HIS OWN WITHOUT THE VENTILATOR. NO ADVERSE PATIENT EVENT. TRACH TUBE IS A SHILEY 6 DCT." 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 (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 KIMVENT CLOSED SUCTION SYSTEM FOR ADULTS CLOSED SUCTION BSY KIMBERLY-CLARK HEALTH CARE M1052T603

    Patients

    Seq Age Sex Outcome Treatment
    1