BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MIC* G-14 INTRODUCER KIT

    MDR report key: 6154135 · Received December 8, 2016

    Report

    Report Number
    9611594-2016-00181
    Event Type
    Malfunction
    Date Received
    December 8, 2016
    Report Date
    November 23, 2016
    Manufacturer
    HALYARD HEALTH
    Product Code
    KGC
    PMA / PMN Number
    PK080253
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    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. THIS PRODUCT INCIDENT IS DOCUMENTED IN THE HALYARD HEALTH COMPLAINT DATABASE AND IDENTIFIED AS (B)(4). DEVICE NOT RETURNED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE HOSPITAL PLACED THE DEVICE USING THE PLACEMENT KIT, AND AFTER 10 DAYS TWO OF THE SUTURES HAD BECOME DISLODGED. NO FURTHER INFORMATION HAS BEEN PROVIDED AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    807486 MIC* G-14 INTRODUCER KIT DIGESTHEALTH ENTERAL FEED PERC PLACEMENT KGC HALYARD HEALTH 98421 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1