BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MIC-KEY* G-14 INTRODUCER KIT

    MDR report key: 6043299 · Received October 20, 2016

    Report

    Report Number
    9611594-2016-00139
    Event Type
    Injury
    Date Received
    October 20, 2016
    Report Date
    December 12, 2016
    Manufacturer
    HALYARD HEALTH
    Product Code
    KGC
    PMA / PMN Number
    PK080253
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE SAMPLE IS REPORTED TO BE AVAILABLE, BUT HAS NOT YET BEEN RECEIVED BY THE MANUFACTURER. THE DEVICE HISTORY RECORD FOR (B)(4) WAS REVIEWED AND THE PRODUCT WAS PRODUCED ACCORDING TO PRODUCT SPECIFICATIONS. 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). DEVICE NOT RETURNED.

    Additional Manufacturer Narrative · 1

    ONE USED SAMPLE WAS RETURNED FOR EVALUATION. VISUAL EXAMINATION REVEALED FOREIGN MATERIAL ATTACHED TO THE T-BAR. THE SUTURE WAS STILL ATTACHED TO THE T-BAR AND APPEARED TO HAVE BROKEN 2.5 CM AWAY FROM THE SUTURE ANCHOR. NO MANUFACTURING ROOT CAUSE COULD BE DETERMINED FOR THE REPORTED ISSUE. THE SUPPLIER CERTIFIED THAT THE COMPONENT WAS IN CONFORMANCE WITH SPECIFICATION AND MEETS ALL REQUIREMENTS NECESSARY FOR PRODUCT RELEASE VIA CERTIFICATE OF CONFORMANCE. 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. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE ANCHORS FROM THE GASTROPEXY INTRODUCTION KITS FAILED AFTER 2 WEEKS. THE ANCHORS WERE IMPLANTED ON (B)(6) 2016. GRANULOMA AND AN ABSCESS HAD FORMED AT THE SITE, AND REQUIRED SURGERY AND DRAINAGE. NO FURTHER INFORMATION HAS BEEN PROVIDED AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    695829 MIC-KEY* G-14 INTRODUCER KIT ENTERAL FEED PERCUTANEOUS KITS KGC HALYARD HEALTH 98431 AA5460R05

    Patients

    Seq Age Sex Outcome Treatment
    1 2 YR Required Intervention