BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MIC-KEY* LOW - PROFILE JEJUNAL FEEDING TUBE

    MDR report key: 7104303 · Received December 11, 2017

    Report

    Report Number
    9611594-2017-00160
    Event Type
    Injury
    Date Received
    December 11, 2017
    Report Date
    November 15, 2017
    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)(4) 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.

    Description of Event or Problem · 1

    IT WAS REPORTED IN THE PUBLICATION THAT "OUR INSTITUTION GENERALLY USED THE MICKEY GJT (HALYARD HEALTH; (B)(6))" 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 (9611594-2017-00160) REPRESENTS ONE OF THE PERFORATIONS. SEE 9611594-2017-00159 FOR THE REPORT THAT REPRESENTS THE OTHER PERFORATION THAT LED TO DEATH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    883630 MIC-KEY* LOW - PROFILE JEJUNAL FEEDING TUBE UNKNOWN KNT HALYARD HEALTH UNKNOWN UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Other