BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    KIMVENT MULTI-PORT, DSY, ENDO, REP CATH 16FR, ALT CODE 240165

    MDR report key: 5472439 · Received March 1, 2016

    Report

    Report Number
    8030647-2016-00031
    Event Type
    Malfunction
    Date Received
    March 1, 2016
    Date of Event
    January 13, 2016
    Report Date
    February 5, 2016
    Manufacturer
    HALYARD HEALTH
    Product Code
    BSY
    PMA / PMN Number
    PEXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE HISTORY RECORD FOR THE LOT NUMBER, M4069T802, INVOLVED IN THIS COMPLAINT WAS REVIEWED AND THE MATERIAL WAS PRODUCED ACCORDING TO THE MANUFACTURING PROCEDURES AND MET THE QUALITY REQUIREMENTS. THE PRODUCT INVOLVED IN THE REPORT HAS BEEN RETURNED AND IS BEING PROCESSED FOR EVALUATION. UPON COMPLETION OF THE SAMPLE EVALUATION; 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).

    Additional Manufacturer Narrative · 1

    ONE USED ENDOSCOPE INLET WITH PRODUCT LABEL WAS RECEIVED FOR EVALUATION. THE DEVICE WAS EXAMINED AND IT WAS DETERMINED THAT THE ENDOSCOPE INLET PORT SEAL WAS IN PLACE AND INTACT. NO OBSTRUCTION OR OCCLUSION COULD BE IDENTIFIED IN THE RETURNED DEVICE. THE COMPLAINT COULD NOT BE CONFIRMED. 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.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED FROM (B)(6) STATING THE ENDOSCOPE INLET FITTING ON THE PATIENT'S CLOSED SUCTION SYSTEM CONTAINED A DEFECT. AS A CONSEQUENCE THERE WAS AN AIR LEAKAGE WHICH RESULTED IN POOR VENTILATION TO THE PATIENT. THE DEVICE WAS REMOVED. NO ADDITIONAL INFORMATION WAS PROVIDED IN REGARDS TO THE PATIENT'S STATUS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    127246 KIMVENT MULTI-PORT, DSY, ENDO, REP CATH 16FR, ALT CODE 240165 VAP CLOSED SUCTION CATHETERS & ACCESSORIES BSY HALYARD HEALTH 240165-5 M4069T802

    Patients

    Seq Age Sex Outcome Treatment
    1