BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MIC* TJ FEEDING TUBE KIT 18 FR, 22CM (ENDO/RADIOL)

    MDR report key: 4933049 · Received July 22, 2015

    Report

    Report Number
    9611594-2015-00126
    Event Type
    Malfunction
    Date Received
    July 22, 2015
    Date of Event
    June 24, 2015
    Report Date
    July 1, 2015
    Manufacturer
    HALYARD HEALTH
    Product Code
    KGC
    PMA / PMN Number
    PK080253
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE ACTUAL COMPLAINT PRODUCT WAS NOT RETURNED FOR EVALUATION. ACCORDING TO THE DEVICE HISTORY RECORD RECORDS, THE PRODUCT WAS MANUFACTURED ACCORDING TO THE APPROVED MANUFACTURING PROCEDURES, SPECIFICATIONS, AND THEN RELEASED BY QUALITY ASSURANCE. 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 (B)(4). DEVICE NOT RETURNED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE FEEDING TUBE SPLIT BELOW THE GASTRIC PORT. THE TUBE WAS IN PLACE FOR APPROXIMATELY ONE MONTH. THE TUBE WAS REPLACED IN RADIOLOGY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    477140 MIC* TJ FEEDING TUBE KIT 18 FR, 22CM (ENDO/RADIOL) DH EF BALLOON TUBES PRODUCTS KGC HALYARD HEALTH 0250-18-22 AA5082N03

    Patients

    Seq Age Sex Outcome Treatment
    1