BEUDAMED
    FDA Adverse Event Death Summary report: N

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

    MDR report key: 7391239 · Received April 2, 2018

    Report

    Report Number
    8030647-2018-00202
    Event Type
    Death
    Date Received
    April 2, 2018
    Date of Event
    March 6, 2018
    Report Date
    May 24, 2018
    Manufacturer
    HALYARD HEALTH
    Product Code
    BSY
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    HALYARD HEALTH RECEIVED ONE USED SUCTION CATHETER WITH THE EMPTY PRODUCT PACKAGING. THE SAMPLE WAS RECEIVED WITH WHAT APPEARED TO BE DRIED BLOOD THROUGHOUT THE SUCTION CATHETER TUBING AND INSIDE THE MANIFOLD. MOST OF THIS WAS REMOVED DURING DECONTAMINATION. THE SAMPLE WAS RECEIVED WITH THE METERED DOSE INHALER DETACHED FROM THE MANIFOLD. THE MANIFOLD WAS BROKEN AT THE PORT WHERE THE MDI TUBING IS INSERTED. THE BOND OF THE TUBING TO THE MOLDED MANIFOLD PORT WAS INTACT. THE EDGES OF THE BREAK WERE JAGGED. THE MOLD CAVITY NUMBER ON THE MANIFOLD WAS "1". NO OTHER DEFECT OR DAMAGE WAS OBSERVED ON THE SAMPLE. THE ROOT CAUSE WAS RELATED TO MANUFACTURING EQUIPMENT. ALL INFORMATION REASONABLY KNOWN AS OF 18-JUN-2018 HAS BEEN INCLUDED IN THIS HEALTH AUTHORITY REPORT. SHOULD ADDITIONAL INFORMATION BE OBTAINED, A FOLLOW-UP HEALTH AUTHORITY REPORT WILL BE PROVIDED. THE INFORMATION PROVIDED BY HALYARD HEALTH REPRESENTS ALL OF THE KNOWN INFORMATION AT THIS TIME. DESPITE GOOD FAITH EFFORTS TO OBTAIN ADDITIONAL INFORMATION, THE COMPLAINANT / REPORTER WAS UNABLE OR UNWILLING TO PROVIDE ANY FURTHER PATIENT, PRODUCT, OR PROCEDURAL DETAILS TO HALYARD HEALTH. 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

    THE PRODUCT INVOLVED IN THE REPORT HAS BEEN RETURNED AND IS BEING PROCESSED FOR EVALUATION. THE DEVICE HISTORY RECORD FOR THE LOT NUMBER, M7339L615, INVOLVED IN THIS COMPLAINT WAS REVIEWED AND THE MATERIAL WAS PRODUCED ACCORDING TO THE MANUFACTURING PROCEDURES AND MET THE QUALITY REQUIREMENTS. ALL INFORMATION REASONABLY KNOWN AS OF (B)(6) 2018 HAS BEEN INCLUDED IN THIS HEALTH AUTHORITY REPORT. SHOULD ADDITIONAL INFORMATION BE OBTAINED, A FOLLOW-UP HEALTH AUTHORITY REPORT WILL BE PROVIDED. THE INFORMATION PROVIDED BY HALYARD HEALTH REPRESENTS ALL OF THE KNOWN INFORMATION AT THIS TIME. DESPITE GOOD FAITH EFFORTS TO OBTAIN ADDITIONAL INFORMATION, THE COMPLAINANT / REPORTER WAS UNABLE OR UNWILLING TO PROVIDE ANY FURTHER PATIENT, PRODUCT, OR PROCEDURAL DETAILS TO HALYARD HEALTH. 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).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT¿S ADAPTER CAME OFF CAUSING A LEAK. THE DEVICE WAS CHANGED BY CLINICIAN WHO STATED THERE WAS NO PATIENT INJURY AND NO DECREASE IN SATURATION. THE PATIENT EXPIRED; HOWEVER, THE CAUSE OF DEATH WAS NOT A RESULT OF THE REPORTED EVENT. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    233844 KIMVENT 14FR DSE 21.3IN/54CM (GREEN) VAP CLOSED SUCTION CATHETERS & ACCESSORIES BSY HALYARD HEALTH 22108 M7339L615

    Patients

    Seq Age Sex Outcome Treatment
    1 91 YR Death| O