BEUDAMED
    FDA Adverse Event Death Summary report: N

    MIC* G-18 INTRODUCER KIT

    MDR report key: 3768833 · Received April 23, 2014

    Report

    Report Number
    9611594-2014-00025
    Event Type
    Death
    Date Received
    April 23, 2014
    Date of Event
    March 26, 2014
    Report Date
    March 31, 2017
    Manufacturer
    KIMBERLY-CLARK HEALTH CARE
    Product Code
    KGC
    PMA / PMN Number
    PK080253
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HISTORY RECORD WAS REVIEWED AND DOCUMENTED THAT THE PRODUCT LOT REPORTED IN THE INCIDENT MET MANUFACTURING SPECIFICATIONS. A SAMPLE WAS NOT RETURNED TO KIMBERLY-CLARK BY THE CUSTOMER. INFORMATION FROM THIS INCIDENT WILL BE INCLUDED IN OUR PRODUCT COMPLAINT AND MDR TREND REPORTING SYSTEMS. ONGOING ANALYSIS OF TREND INFORMATION IS USED TO IDENTIFY THE NEED FOR ADDITIONAL INVESTIGATIONS. DEVICE NOT RETURNED BY CUSTOMER.

    Additional Manufacturer Narrative · 1

    (B)(4). PER A REVIEW OF THE COMPLAINT, THE FOLLOWING HAVE BEEN CORRECTED: DEVICE PRODUCT CODE, NAME AND ADDRESS, HEALTH PROFESSIONAL?, OCCUPATION, CONTACT OFFICE. 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

    ALL INFORMATION REASONABLY KNOWN AS OF 27APR2017 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).

    Description of Event or Problem · 1

    KIMBERLY-CLARK RECEIVED A REPORT STATING, ¿WHILE A FELLOW WAS PERFORMING A TUBE PLACEMENT PROCEDURE, PART OF THE SERIAL DILATOR BECAME DETACHED AND WAS RETAINED IN PATIENT'S STOMACH. AN ATTEMPT WAS MADE TO RECOVER THE PORTION ENDOSCOPICALLY BUT WAS NOT SUCCESSFUL. THE PATIENT WAS SENT TO THE OPERATING ROOM TO HAVE A LAPAROTOMY PERFORMED TO REMOVE THE RETAINED PORTION OF THE DILATOR. THE PATIENT RECOVERED WITHOUT FURTHER INCIDENT.¿ (B)(4).

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED 15-SEP-2016 STATED THAT THE PATIENT EXPIRED ON (B)(6) 2015.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED FROM FDA REPORT NUMBER FDA 3500 FORM 3840327. THE REPORT STATES, "PATIENT WAS TRANSFERRED TO OPERATING ROOM FOR AN EXPLORATORY LAPAROTOMY TO REMOVE DILATOR. GASTROSTOMY TUBE WAS PLACED WHILE IN THE OPERATING ROOM."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    246051 MIC* G-18 INTRODUCER KIT ENTERAL FEEDING TUBE KGC KIMBERLY-CLARK HEALTH CARE 98423 AA4042R04

    Patients

    Seq Age Sex Outcome Treatment
    1 Death