BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MIC-KEY* G-20 LAPAROSCOPIC INTRODUCER KIT

    MDR report key: 6218374 · Received January 3, 2017

    Report

    Report Number
    9611594-2016-00185
    Event Type
    Malfunction
    Date Received
    January 3, 2017
    Date of Event
    December 9, 2016
    Report Date
    January 9, 2017
    Manufacturer
    HALYARD HEALTH
    Product Code
    KCG
    UDI-DI
    10680651102260
    PMA / PMN Number
    K080253
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    ATTORNEY

    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 A LOT NUMBER WAS NOT PROVIDED. ROOT CAUSE CANNOT 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).

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION, 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 COMPLAINT COMP-(B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT HAD A PROCEDURE TO PLACE A MIC-KEY FEEDING TUBE. ON (B)(6) 2016 THE PATIENT PICKED AT THE SCAB WOUND AND ALLEGED THAT A SMALL PIECE OF METAL CAME FROM THE SCAB AREA. ADDITIONAL INFORMATION WAS RECEIVED ON 20-DEC-2016 FROM THE HALYARD REPRESENTATIVE WHO WAS PRESENT DURING THE PATIENT'S PROCEDURE ON (B)(6) 2016. THE HALYARD REPRESENTATIVE STATES THE PROCEDURE WAS DONE LAPAROSCOPY AND THE T-FASTENERS WERE PLACED CORRECTLY, AND THE T-FASTENERS WERE NOT TIGHT. THE PHYSICIAN COMPLETED THE PROCEDURE WITH THE CORRECT TECHNIQUE. THE WERE NO ISSUES OR CONCERNS WITH THE PROCEDURE THAT LASTED APPROXIMATELY TEN MINUTES. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED ON (B)(6) 2017 THAT STATES, A PATIENT GOT AN X-RAY LAST WEEK FOUND SOME OTHER METALS AND THE PATIENT WILL HAVE ANOTHER PROCEDURE TO REMOVE THE METALS. NO ADDITIONAL INFORMATION PROVIDED AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1092 MIC-KEY* G-20 LAPAROSCOPIC INTRODUCER KIT DIGESTHEALTH ENTERAL FEED PERC PLACEMENT KCG HALYARD HEALTH 10226 UNKNOWN 10680651102260

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR