BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MIC-KEY* G-18 INTRODUCER KIT

    MDR report key: 6104354 · Received November 15, 2016

    Report

    Report Number
    9611594-2016-00169
    Event Type
    Malfunction
    Date Received
    November 15, 2016
    Date of Event
    October 24, 2016
    Report Date
    October 24, 2016
    Manufacturer
    HALYARD HEALTH
    Product Code
    KGC
    PMA / PMN Number
    PK080253
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE ACTUAL COMPLAINT PRODUCT WAS NOT RETURNED FOR EVALUATION. THE DEVICE HISTORY RECORD FOR THE LOT NUMBER, AA6116R13, INVOLVED IN THIS COMPLAINT WAS REVIEWED AND THE MATERIAL WAS PRODUCED ACCORDING TO THE MANUFACTURING PROCEDURES AND MET THE QUALITY REQUIREMENTS. THERE WERE NO NONCONFORMANCE(S), OR ABNORMAL CONDITIONS NOTED AT THE TIME OF PRODUCTION. AT THE TIME OF THE DHR REVIEW, THERE WERE NO CHANGES TO THE PROCESS AND/OR EQUIPMENT THAT WOULD HAVE AFFECTED THE MANUFACTURING OF THE DEVICE. 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. (B)(4).

    Description of Event or Problem · 1

    HALYARD RECEIVED A SINGLE REPORT THAT REFERENCED TWO DIFFERENT INCIDENCES, WHICH WERE ASSOCIATED WITH SEPARATE UNITS, INVOLVING TWO DIFFERENT PATIENTS. THIS IS THE SECOND OF TWO REPORTS. REFER TO 9611594-2016-00168 FOR THE FIRST PATIENT. IT WAS REPORTED THAT THE T-FASTENER ANCHORS BROKE AFTER PLACEMENT WITH NO REPORTED PATIENT INJURY. THIS INCIDENT OCCURRED WITH TWO KITS. NO ADDITIONAL INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    753450 MIC-KEY* G-18 INTRODUCER KIT DH EF PERC PLACEMENT PRODUCTS KGC HALYARD HEALTH 98433 AA6116R13

    Patients

    Seq Age Sex Outcome Treatment
    1