BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    KIMVENT 8FR ELBOW 14IN/35.5CM (LIGHT BLUE)

    MDR report key: 5239342 · Received November 20, 2015

    Report

    Report Number
    8030647-2015-00277
    Event Type
    Malfunction
    Date Received
    November 20, 2015
    Report Date
    October 26, 2015
    Manufacturer
    HALYARD HEALTH
    Product Code
    BSY
    PMA / PMN Number
    PEXEMPT
    Removal / Correction Number
    FDA RECALL # Z-2522-2015
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    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 NO LOT NUMBER WAS PROVIDED. (B)(6) 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CUSTOMERS HAD ONGOING ISSUES WITH THE CLOSED SUCTION CATHETERS THUMB PORT. NO ADDITIONAL INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    770398 KIMVENT 8FR ELBOW 14IN/35.5CM (LIGHT BLUE) VAP CLOSED SUCTION CATH NEO/PEDI BSY HALYARD HEALTH 208 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1