BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MIC-KEY* G-16 INTRODUCER KIT

    MDR report key: 6111621 · Received November 17, 2016

    Report

    Report Number
    9611594-2016-00171
    Event Type
    Malfunction
    Date Received
    November 17, 2016
    Date of Event
    October 26, 2016
    Report Date
    November 1, 2016
    Manufacturer
    HALYARD HEALTH
    Product Code
    KGC
    PMA / PMN Number
    PK080253
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE ACTUAL COMPLAINT PRODUCT WAS NOT RETURNED FOR EVALUATION. ROOT CAUSE COULD NOT BE DETERMINED. A REVIEW OF THE DEVICE HISTORY RECORD IS NOT POSSIBLE AS NO LOT NUMBER WAS PROVIDED. 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 ONE OF THE PATIENT'S ANCHOR SUTURES HAD FAILED THE NIGHT AFTER HAVING THE MIC KEY DEVICE PLACED ON (B)(6) 2016, FOLLOWING A CARDIOPLASTY PROCEDURE. THE REMAINING ANCHORS WERE TAPED IN PLACE. ON (B)(6) 2016 ANOTHER ANCHOR FAILED. THERE WAS NO AFFECT ON THE MIC KEY DEVICE. THERE WAS NO INJURY TO PATIENT. A COMPUTERIZED TOMOGRAPHY (CT) SCAN WAS PERFORMED TO CONFIRM THAT THE T BARS REMAINED INSIDE THE PATIENT. THE PATIENT WAS NOT ACTIVE AND USUALLY WATCHED TV IN A SITTING POSITION. THE SUTURE ANCHORS HAD BEEN LOCKED WITH ABOUT 5 MM CLEARANCE BETWEEN THE ABDOMINAL WALL AND THE ANCHOR. A PASSAGE MADE FOR CARDIOPLASTY WAS DILATED AND WAS USED AS STOMA FOR MIC-KEY. NO FURTHER INFORMATION HAS BEEN PROVIDED AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    761847 MIC-KEY* G-16 INTRODUCER KIT ENTERAL FEED PERCUTANEOUS KITS KGC HALYARD HEALTH 98432 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 12 YR