BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    KIMVENT 14FR DSE 21.3IN/54CM (GREEN)

    MDR report key: 5910079 · Received August 29, 2016

    Report

    Report Number
    8030647-2016-00174
    Event Type
    Malfunction
    Date Received
    August 29, 2016
    Date of Event
    August 8, 2016
    Report Date
    August 8, 2016
    Manufacturer
    HALYARD HEALTH
    Product Code
    BSY
    PMA / PMN Number
    PEXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    UDI # UNKNOWN. (B)(4). A REPRESENTATIVE SAMPLE WAS RECEIVED FOR EVALUATION. ONE UNOPENED PACKAGE OF CODE 8224 (WET PACK) WAS RECEIVED - LOT AB6060U14. THE CLOSED SUCTION CATHETER INSIDE THE WET PACK IS LOT M6007T649. THE CONNECTION OF THE MATING COMPONENTS WAS CHECKED. THE CONNECTION OF THE HYH FLEX CONNECTOR TO THE DOUBLE SWIVEL ELBOW MALE INSERT (DSE) DOES NOT DISPLAY ANY CONNECTION ISSUE. BASED ON THE SAMPLE EVALUATION THE FAILURE WAS NOT CONFIRMED. THE DEVICE HISTORY RECORD FOR THE LOT NUMBER, M6018T639, INVOLVED IN THIS COMPLAINT WAS REVIEWED AND THE MATERIAL WAS PRODUCED ACCORDING TO THE MANUFACTURING PROCEDURES AND MET THE QUALITY REQUIREMENTS. 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. (B)(4). REPRESENTATIVE SAMPLE RECEIVED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT, ON THE CLOSED SUCTION CATHETER, THE SIDE VENT PORT OF THE ELBOW ON THE CATHETER SEEMS TO APPEAR TOO SMALL AND LOOSE FOR THE VENTILATOR CIRCUIT OR (HME) HEAT MOISTURE EXCHANGER OR OTHER DEVICES FOR A TIGHT CONNECTION. MEDICAL INTERVENTION IS PROVIDED WHEN THE PATIENT LOSES CONTACT WITH THE VENTILATOR BY REATTACHING THE CATHETERS. THERE WAS NO PATIENT INJURY REPORTED. NO FURTHER INFORMATION HAS BEEN PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    561724 KIMVENT 14FR DSE 21.3IN/54CM (GREEN) VAP CLOSED SUCTION CATH ADULT BSY HALYARD HEALTH 8224 M6018T639

    Patients

    Seq Age Sex Outcome Treatment
    1