BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MIC* TJ FEEDING TUBE KIT 18 FR, 45CM (ENDO/RADIOL)

    MDR report key: 5123772 · Received October 2, 2015

    Report

    Report Number
    9611594-2015-00173
    Event Type
    Malfunction
    Date Received
    October 2, 2015
    Report Date
    September 29, 2015
    Manufacturer
    HALYARD HEALTH
    Product Code
    KGC
    PMA / PMN Number
    PK921370
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). 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. A ROOT CAUSE COULD NOT BE DETERMINED. 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.

    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 (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

    HALYARD RECEIVED A SINGLE REPORT THAT REFERENCED THREE DIFFERENT INCIDENCES, WHICH WERE ASSOCIATED WITH SEPARATE UNITS, INVOLVING ONE PATIENT. THIS IS THE THIRD OF THREE REPORTS. REFER TO MDR # 9611594-2015-00171 FOR THE FIRST REPORT. REFER TO MDR # 9611594-2015-00172 FOR THE SECOND REPORT. IT WAS REPORTED THAT THE PATIENT'S ENTERAL FEEDING TUBE WAS REPLACED WITHIN ABOUT A MONTH OF PLACING IT DUE TO BALLOON FAILURE. THERE ARE NO REPORTED ADVERSE EVENT AS IT RELATES TO THE TUBE EXCHANGE.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED ON 09/29/2015 STATED THE DEVICE FAILED WITHIN ONE MONTH OF USE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    654314 MIC* TJ FEEDING TUBE KIT 18 FR, 45CM (ENDO/RADIOL) DIGEST HEALTH EF BALLOON TUBES PRODUCTS KGC HALYARD HEALTH 0250-18 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1