BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    KIMVENT ORAL CARE SUCTION SWAB 40

    MDR report key: 6118844 · Received November 21, 2016

    Report

    Report Number
    8030647-2016-00224
    Event Type
    Malfunction
    Date Received
    November 21, 2016
    Date of Event
    November 8, 2016
    Report Date
    January 27, 2017
    Manufacturer
    HALYARD HEALTH
    Product Code
    JOL
    PMA / PMN Number
    PEXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    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). THIS INFORMATION IS SUBMITTED PURSUANT TO 21CFR803, IN COMPLIANCE WITH THE MEDICAL DEVICE REPORTING REQUIREMENT AND SHOULD NOT BE CONSIDERED TO BE AN ADMISSION THAT A HALYARD HEALTH PRODUCT IS DEFECTIVE OR CAUSED SERIOUS INJURY.

    Additional Manufacturer Narrative · 1

    (B)(4). THE ACTUAL COMPLAINT PRODUCT WAS NOT RETURNED FOR EVALUATION. A REVIEW OF THE DEVICE HISTORY RECORD IS NOT POSSIBLE AS THE CORRECT LOT NUMBER WAS NOT RECEIVED. ROOT CAUSE COULD NOT BE DETERMINED. 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). SAMPLE NOT AVAILABLE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A SUCTION SWAB CAME OFF DURING USE. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    766880 KIMVENT ORAL CARE SUCTION SWAB 40 ORAL CARE KIMVENT COMPONENTS JOL HALYARD HEALTH 99790 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1