BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTRODUCER KIT FOR GASTROSTOMY FEEDING TUBE, 20FR DILATOR

    MDR report key: 7681128 · Received July 12, 2018

    Report

    Report Number
    9611594-2018-00084
    Event Type
    Malfunction
    Date Received
    July 12, 2018
    Date of Event
    June 13, 2018
    Report Date
    August 28, 2018
    Manufacturer
    HALYARD HEALTH
    Product Code
    KGC
    UDI-DI
    10680651984323
    PMA / PMN Number
    K080253
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THE PRODUCT INVOLVED IN THE REPORT HAS BEEN RETURNED AND IS BEING PROCESSED FOR EVALUATION. ALL INFORMATION REASONABLY KNOWN AS OF 01 AUG 2018 HAS BEEN INCLUDED IN THIS HEALTH AUTHORITY REPORT. SHOULD ADDITIONAL INFORMATION BE OBTAINED, A FOLLOW-UP HEALTH AUTHORITY REPORT WILL BE PROVIDED. THE INFORMATION PROVIDED BY HALYARD HEALTH REPRESENTS ALL OF THE KNOWN INFORMATION AT THIS TIME. DESPITE GOOD FAITH EFFORTS TO OBTAIN ADDITIONAL INFORMATION, THE COMPLAINANT / REPORTER WAS UNABLE OR UNWILLING TO PROVIDE ANY FURTHER PATIENT, PRODUCT, OR PROCEDURAL DETAILS TO HALYARD HEALTH. 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 (B)(4).

    Additional Manufacturer Narrative · 0

    THREE SUTURES WERE RECEIVED FOR EVALUATION. EACH SAMPLE WAS RECEIVED WITH THE SOFT SHELL ATTACHED TO THE CLAMP BASE. NONE OF THE SUTURES SHOWED SIGNS OF BREAKAGE. THE COMPLAINT COULD NOT BE CONFIRMED AS REPORTED. THE ROOT CAUSE COULD NOT BE DETERMINED. ALL INFORMATION REASONABLY KNOWN AS OF 14 SEP 2018 HAS BEEN INCLUDED IN THIS HEALTH AUTHORITY REPORT. SHOULD ADDITIONAL INFORMATION BE OBTAINED, A FOLLOW-UP HEALTH AUTHORITY REPORT WILL BE PROVIDED. THE INFORMATION PROVIDED BY HALYARD HEALTH REPRESENTS ALL OF THE KNOWN INFORMATION AT THIS TIME. DESPITE GOOD FAITH EFFORTS TO OBTAIN ADDITIONAL INFORMATION, THE COMPLAINANT / REPORTER WAS UNABLE OR UNWILLING TO PROVIDE ANY FURTHER PATIENT, PRODUCT, OR PROCEDURAL DETAILS TO HALYARD HEALTH. 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 (B)(4).

    Additional Manufacturer Narrative · 1

    THE SAMPLE IS REPORTED TO BE AVAILABLE, BUT HAS NOT YET BEEN RECEIVED BY THE MANUFACTURER. THE DEVICE HISTORY RECORD FOR LOT AA8015R06 WAS REVIEWED AND THE PRODUCT WAS PRODUCED ACCORDING TO PRODUCT SPECIFICATIONS. ALL INFORMATION REASONABLY KNOWN AS OF 10 JUL 2018 HAS BEEN INCLUDED IN THIS HEALTH AUTHORITY REPORT. SHOULD ADDITIONAL INFORMATION BE OBTAINED, A FOLLOW-UP HEALTH AUTHORITY REPORT WILL BE PROVIDED. THE INFORMATION PROVIDED BY HALYARD HEALTH REPRESENTS ALL OF THE KNOWN INFORMATION AT THIS TIME. DESPITE GOOD FAITH EFFORTS TO OBTAIN ADDITIONAL INFORMATION, THE COMPLAINANT / REPORTER WAS UNABLE OR UNWILLING TO PROVIDE ANY FURTHER PATIENT, PRODUCT, OR PROCEDURAL DETAILS TO HALYARD HEALTH. 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 (B)(4). DEVICE NOT RETURNED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AFTER PLACEMENT OF THE ANCHORS, THREE OF THEM DID NOT STAY FIXED. ANOTHER KIT WAS OPENED TO COMPLETE THE PROCEDURE. NO FURTHER INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    525176 INTRODUCER KIT FOR GASTROSTOMY FEEDING TUBE, 20FR DILATOR DH EF PERC PLACEMENT PRODUCTS KGC HALYARD HEALTH 98432 AA8015R06 10680651984323

    Patients

    Seq Age Sex Outcome Treatment
    1