BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MIC-KEY* G-20 INTRODUCER KIT

    MDR report key: 6123919 · Received November 23, 2016

    Report

    Report Number
    9611594-2016-00172
    Event Type
    Malfunction
    Date Received
    November 23, 2016
    Date of Event
    November 7, 2016
    Report Date
    November 7, 2016
    Manufacturer
    HALYARD HEALTH
    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 NOT POSSIBLE AS NO LOT NUMBER WAS PROVIDED. ROOT CAUSE COULD NOT BE DETERMINED. 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). SAMPLE IS NOT AVAILABLE.

    Description of Event or Problem · 1

    HALYARD RECEIVED A SINGLE REPORT THAT REFERENCED THREE DIFFERENT INCIDENCES, WHICH WERE ASSOCIATED WITH SEPARATE UNITS, INVOLVING ONE PATIENT. THIS IS THE FIRST OF THREE REPORTS. REFER TO 9611594-2016-00173 FOR THE SECOND REPORT. REFER TO 9611594-2016-00174 FOR THE THIRD REPORT. IT WAS REPORTED A T-FASTENER SNAPPED WITH THE KIT PRIOR TO USING IT ON A PATIENT. THE PHYSICIAN OPENED TWO ADDITIONAL KITS AND THE SAME ISSUE OCCURRED. NO ADDITIONAL INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    776615 MIC-KEY* G-20 INTRODUCER KIT ENTERAL FEED PERCUTANEOUS KITS KGC HALYARD HEALTH 98434-17 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1