BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MIC-KEY LOW-PROFILE TRANSGASTRIC-JEJUNAL FEE

    MDR report key: 4344774 · Received December 10, 2014

    Report

    Report Number
    9611594-2014-00174
    Event Type
    Malfunction
    Date Received
    December 10, 2014
    Report Date
    November 10, 2014
    Manufacturer
    HALYARD HEALTH, INC.
    Product Code
    KNT
    PMA / PMN Number
    K043114
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SW
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT INVOLVED IN THE REPORT HAS BEEN RETURNED AND IS BEING PROCESSED FOR EVALUATION. A REVIEW OF THE DEVICE HISTORY RECORD IS IN-PROGRESS. UPON COMPLETION OF THE INVESTIGATION; A FOLLOW-UP REPORT WILL BE FILED. (B)(4) 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 (B)(4) COMPLAINT DATABASE AND IDENTIFIED AS COMPLAINT (B)(4).

    Additional Manufacturer Narrative · 1

    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).

    Additional Manufacturer Narrative · 1

    THE DEVICE HISTORY RECORD FOR THE LOT NUMBER INVOLVED IN THIS COMPLAINT WAS REVIEWED AND THE MATERIAL WAS PRODUCED ACCORDING TO THE MANUFACTURING PROCEDURES AND MET THE QUALITY REQUIREMENTS. AS STATED IN THE INSTRUCTIONS FOR USE, "THIS DEVICE REQUIRES PERIODIC (RANGE 1 TO 8 MONTHS) REPLACEMENT, AND SEVERAL FACTORS CAN IMPACT THE LONGEVITY OF THE DEVICE. BASED ON THE AVAILABLE INFORMATION AND ANALYSIS, A ROOT CAUSE FOR THE REPORTED FAILURE COULD NOT BE DETERMINED." ONE SAMPLE DEVICE WAS RECEIVED. NO PACKAGING WAS RECEIVED WITH THE SAMPLE DEVICE. THE BALLOON EXHIBITED A RADIAL BURST. THE BALLOON MATERIAL WAS INSPECTED UNDER MAGNIFICATION. NO OBVIOUS DEFECT WAS OBSERVED ON THE MATERIAL THAT COULD IDENTIFY A POTENTIAL POINT OF ORIGIN FOR THE BURST. 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

    (B)(6) RECEIVED A REPORT FROM (B)(6) STATING THE ENTERAL FEEDING TUBE BALLOON BROKE AND THE DEVICE FAILED AFTER FOUR WEEKS IN USE. THE PATIENT WENT TO THE HOSPITAL AND THE DEVICE WAS CHANGED. NO ADDITIONAL INFORMATION WAS PROVIDED IN REGARDS TO THE PATIENT'S STATUS. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT NOT YET RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    797024 MIC-KEY LOW-PROFILE TRANSGASTRIC-JEJUNAL FEE ENTERNAL FEEDING TUBE KNT HALYARD HEALTH, INC. 0270-18-3.5-45 AA334N46

    Patients

    Seq Age Sex Outcome Treatment
    1 Other