BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    KIMVENT 14FR T-PIECE 21.3IN/54CM (GREEN)

    MDR report key: 5141302 · Received October 9, 2015

    Report

    Report Number
    8030647-2015-00231
    Event Type
    Malfunction
    Date Received
    October 9, 2015
    Date of Event
    September 15, 2015
    Report Date
    October 20, 2015
    Manufacturer
    HALYARD HEALTH
    Product Code
    BSY
    PMA / PMN Number
    PEXEMPT
    Removal / Correction Number
    RECALL # Z-2492-2015
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    RESPIRATORY THERAPIST

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE MANUFACTURE DATE APR 25, 2015. THE DEVICE HISTORY RECORD FOR THE LOT NUMBER, M5117T609, INVOLVED IN THIS COMPLAINT WAS REVIEWED AND THE MATERIAL WAS PRODUCED ACCORDING TO THE MANUFACTURING PROCEDURES AND MET THE QUALITY REQUIREMENTS. THE SAMPLE WAS RETURNED. THE POSITION OF THE THUMB VALVE DID APPEARED TO BE FULLY UPRIGHT (CLOSED). AFTER DEPRESSING AND RELEASING THE VALVE, IT DID RETURNED TO THE FULL UPRIGHT POSITION. THE SAMPLE WAS THEN ATTACHED TO MOBIVAC SUCTIONING EQUIPMENT WITH THE SUCTION SET AT 120MMHG. UPON CONNECTION, AIR LEAK SOUND WAS NOT HEARD. THE DISTAL END OF THE CATHETER WAS THEN INSERTED IN A BEAKER WITH METHYLENE BLUE, SUCTIONING DID NOT OCCURRED, WHEN THE THUMB VALVE WAS FULLY DEPRESSED, SUCTIONING INCREASED. THE VALVE WAS PLACED IN THE LOCKED POSITION. SUCTIONING ALSO DID NOT OCCURRED IN THE LOCKED POSITION. HALYARD HEALTH 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 HALYARD HEALTH COMPLAINT DATABASE AND IDENTIFIED AS COMPLAINT (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4). AN ACTUAL PRODUCT SAMPLE WAS NOT RETURNED FOR EVALUATION. UPON COMPLETION OF THE INVESTIGATION; A FOLLOW-UP REPORT WILL BE FILED. HALYARD HEALTH 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 HALYARD HEALTH COMPLAINT DATABASE AND IDENTIFIED AS COMPLAINT (B)(4). DEVICE NOT RETURNED.

    Description of Event or Problem · 1

    THE RESPIRATORY THERAPIST REPORTED THAT A LEAK OCCURRED ON THE CLOSED SUCTION CATHETER AT THE THUMB PORT. THE RESPIRATORY THERAPIST ALSO STATED, THAT THE SUGGESTED FIX FOR TURNING THE VALVE 90 DEGREES DID NOT WORK AND THERE WAS A CONTINUAL LEAK AND TIDAL VOLUME WAS STILL LOW. THE CATHETER WAS SWITCHED OUT AND VOLUMES RETURNED TO BASELINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    670841 KIMVENT 14FR T-PIECE 21.3IN/54CM (GREEN) VAP CLOSED SUCTION CATH ADULT BSY HALYARD HEALTH 2205 M5117T609

    Patients

    Seq Age Sex Outcome Treatment
    1