BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MIC* G-18 INTRODUCER KIT

    MDR report key: 4491685 · Received February 6, 2015

    Report

    Report Number
    9611594-2015-00019
    Event Type
    Malfunction
    Date Received
    February 6, 2015
    Date of Event
    December 30, 2014
    Report Date
    January 8, 2015
    Manufacturer
    HALYARD HEALTH, INC.
    Product Code
    KGC
    PMA / PMN Number
    PK080253
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, 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 IN-PROGRESS. UPON COMPLETION OF THE INVESTIGATION; 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). 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

    HALYARD HEALTH RECEIVED A REPORT STATING AN ENTERAL FEEDING INITIAL PLACEMENT KIT (IPK) WAS USED FOR PLACEMENT OF MIC G-TUBE. WITHIN 24-HOURS OF PLACEMENT THE SUTURES BROKE AT THE INCISION SITE BUT THE TUBE REMAINED INTACT.NO ADDITIONAL INFORMATION WAS PROVIDED IN REGARDS TO THE PATIENT'S STATUS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    87570 MIC* G-18 INTRODUCER KIT ENTERAL FEED PERCUTANEOUS KITS KGC HALYARD HEALTH, INC. 98423 AA4119R09

    Patients

    Seq Age Sex Outcome Treatment
    1