BEUDAMED
    FDA Adverse Event Death Summary report: N

    MIC-KEY* JEJUNAL FEEDING TUBE

    MDR report key: 7104297 · Received December 11, 2017

    Report

    Report Number
    9611594-2017-00159
    Event Type
    Death
    Date Received
    December 11, 2017
    Report Date
    February 6, 2018
    Manufacturer
    HALYARD HEALTH
    Product Code
    KNT
    PMA / PMN Number
    UNKNOWN
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE ACTUAL COMPLAINT PRODUCT WAS NOT RETURNED FOR EVALUATION. A REVIEW OF THE DEVICE HISTORY RECORD IS NOT POSSIBLE AS NO LOT NUMBER WAS PROVIDED. ROOT CAUSE COULD NOT BE DETERMINED. ALL INFORMATION REASONABLY KNOWN AS OF (B)(6) 2017 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.

    Additional Manufacturer Narrative · 1

    REGULATORY PROJECT MANAGER. ALL INFORMATION REASONABLY KNOWN AS OF (B)(6) 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). 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 HALYARD HEALTH PRODUCT IS DEFECTIVE OR CAUSED SERIOUS INJURY.

    Description of Event or Problem · 1

    IT WAS REPORTED IN THE PUBLICATION THAT "OUR INSTITUTION GENERALLY USED THE MICKEY GJT (HALYARD HEALTH (B)(4))" AND THERE WAS AN "INCREASE IN PERFORATIONS WITH TUBE PLACEMENT IN INFANTS." THE EXACT TUBE SIZE WAS NOT NOTED IN THE PUBLICATION; A STOMA LENGTH FOR THE TUBES WAS NOT REFERENCED. THE ARTICLE STATED THAT THE GASTROJEJUNOSTOMY TUBES CAUSED 2 PERFORATIONS AND 1 DEATH. IT IS CURRENTLY UNKNOWN WHICH PRODUCTS CONTRIBUTED TO THE EVENTS AND, THEREFORE, THIS REPORT IS BEING SUBMITTED OUT OF AN ABUNDANCE OF CAUTION. THIS REPORT (9611594-2017-00159) REPRESENTS THE PERFORATION THAT LED TO A DEATH. SEE (9611594-2017-00160) FOR THE REPORT THAT REPRESENTS THE OTHER PERFORATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    883624 MIC-KEY* JEJUNAL FEEDING TUBE DH EF BALLOON TUBES PRODUCTS KNT HALYARD HEALTH UNKNOWN UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 6 MO Death| O