BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MIC-KEY* LOW-PROFILE TRANSGASTRIC-JEJUNAL FEEDING TUBE, 16 FR, 1.5 CM, 45 CM

    MDR report key: 5020418 · Received August 21, 2015

    Report

    Report Number
    9611594-2015-00146
    Event Type
    Malfunction
    Date Received
    August 21, 2015
    Date of Event
    August 2, 2015
    Report Date
    October 21, 2015
    Manufacturer
    HALYARD HEALTH
    Product Code
    KNT
    PMA / PMN Number
    PK922667
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HISTORY RECORD FOR THE LOT NUMBER, AA4272N39, INVOLVED IN THIS COMPLAINT WAS REVIEWED AND THE MATERIAL WAS PRODUCED ACCORDING TO THE MANUFACTURING PROCEDURES AND MET THE QUALITY REQUIREMENTS. ONE SAMPLE DEVICE WAS RETURNED. THE TUBING WAS SEVERED FLUSH FROM THE BASE OF THE MOLDED HEAD ON THE DEVICE. THE BOND ON THE TUBING TO THE MOLDED HEAD WAS INTACT. THE POINT OF SEPARATION APPEARED RELATIVELY SMOOTH, WITH ONE AREA NOTED AS MORE JAGGED. 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

    (B)(4).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

    (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. 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

    A REPORT WAS RECEIVED FROM THE (B)(6) STATING THE TRANSGASTRIC ENTERAL FEEDING TUBE BROKE. THE DEVICE WAS PLACED ON (B)(6) 2015 AND ON (B)(6) 2015 THE END PORTION OF THE TUBE SNAPPED OFF, WHICH INCLUDED THE Y-PORT INCLUDING BALLOON PORT, JEJUNAL AND GASTRIC PORT. ADDITIONAL INFORMATION RECEIVED 08/04/2015 STATED THE FAMILY OF THE PATIENT ARE EXTREMELY COMPETENT WITH THE MANAGEMENT OF THE DEVICE. THIS PARTICULAR PATIENT HAS HAD A MIC TRANSGASTRIC JEJUNAL ENTERAL FEEDING TUBE FOR OVER 4-YEARS, USUALLY REQUIRING INFREQUENT REPLACEMENTS. THE PATIENTS MOTHER IS THE PRIMARY CAREGIVER. NO ADDITIONAL INFORMATION WAS PROVIDED IN REGARDS TO THE PATIENT'S STATUS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    556476 MIC-KEY* LOW-PROFILE TRANSGASTRIC-JEJUNAL FEEDING TUBE, 16 FR, 1.5 CM, 45 CM ENTERAL FEEDING TUBE KNT HALYARD HEALTH 0270-16-1.5-45 AA4272N39

    Patients

    Seq Age Sex Outcome Treatment
    1