BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HALYARD* ORAL CARE Q4 KIT WITH CHG

    MDR report key: 6945955 · Received October 12, 2017

    Report

    Report Number
    8030647-2017-00110
    Event Type
    Malfunction
    Date Received
    October 12, 2017
    Date of Event
    September 14, 2017
    Report Date
    November 15, 2017
    Manufacturer
    HALYARD HEALTH
    Product Code
    JOL
    UDI-DI
    30680651139031
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HISTORY RECORD FOR THE LOT NUMBER, 0202766516, INVOLVED IN THIS COMPLAINT WAS REVIEWED AND THE MATERIAL WAS PRODUCED ACCORDING TO THE MANUFACTURING PROCEDURES AND MET THE QUALITY REQUIREMENTS. A ROOT CAUSE WAS NOT DETERMINED AT THIS TIME. ALL INFORMATION REASONABLY KNOWN AS OF 04DECT2017 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 ACTUAL COMPLAINT PRODUCT WAS NOT RETURNED FOR EVALUATION. A REVIEW OF THE DEVICE HISTORY RECORD IS IN-PROGRESS; A FOLLOW-UP REPORT WILL BE FILED. ALL INFORMATION REASONABLY KNOWN AS OF 12OCT2017 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 (B)(4). DEVICE NOT RETURNED

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAD AN ISSUE OVERNIGHT WITH THE SPONGE FALLING OFF INTO THE PATIENT'S MOUTH. THE PATIENT WAS REPORTEDLY NOT BITING. THE SPONGE HAD GOTTEN BETWEEN HE ENDOTRACHEAL TUBE AND ANOTHER COMPONENT OF THE ENDOTRACHEAL TUBE'S SETUP, BUT WAS NOT FORCED IN OR OUT TO CAUSE THE SPONGE TO BE FORCEFULLY REMOVED. THE SWAB AND WAS RETRIEVED BY THE NURSE. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    724675 HALYARD* ORAL CARE Q4 KIT WITH CHG VAP ORAL CARE PRODUCTS JOL HALYARD HEALTH 97014 0202766516 30680651139031

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR