BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MIC-KEY* G-20 INTRODUCER KIT

    MDR report key: 6095918 · Received November 11, 2016

    Report

    Report Number
    9611594-2016-00165
    Event Type
    Malfunction
    Date Received
    November 11, 2016
    Date of Event
    September 30, 2016
    Report Date
    October 21, 2016
    Manufacturer
    HALYARD HEALTH
    Product Code
    KGC
    PMA / PMN Number
    PK080253
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    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. (B)(4) 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 (B)(4) 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 (B)(4) PRODUCT IS DEFECTIVE OR CAUSED SERIOUS INJURY. SAMPLE NOT RETURNED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING THE PROCEDURE, ONE OF THE ANCHOR SUTURES BROKE. THERE WAS NO REPORTED CONSEQUENCES FOR THE PATIENT. NO FURTHER INFORMATION HAS BEEN PROVIDED AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    748173 MIC-KEY* G-20 INTRODUCER KIT ENTERAL FEED PERCUTANEOUS KITS KGC HALYARD HEALTH 98434-17 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 31 YR